HHSC Drug Utilization Review Board – October 23, 2026

The Drug Utilization Review Board (DURB) met on October 23^rd to take up various agenda items. They heard from invited and public testimony. The archived video can be found here. The list of committee members can be found here. The agenda can be found here.

This report is intended to give you an overview and highlight the various topics taken up. It is not a verbatim transcript of the discussions but is based upon what was audible or understandable to the observer. This report was written and reviewed by human authors.

 

Agenda item 2: Generous Model Announcement- Vendor Drug Program

Dr. Justin Luong, DUR and Formulary Management Director, Texas Vendor Drug Program

• The generous model is a CMS center initiative designed to lower Medicaid prescription drug spending and aligns prices with selected foreign countries
• Generous model applies to covered outpatient drugs and uses the CMS led negotiations with drug manufacturers
• CMS will monitor the accuracy of the payment structure
• Generous model is a 5-year voluntary Medicaid drug pricing initiative that was launched January 2026
• On September 18^th, 2026, CMS announced Allstate Medicaid programs plus the district of Colombia and Puerto Rico have applied to participate
• For more information, please visit CMS.gov

 

Agenda item 3: Consideration of July 24, 2026, draft meeting minutes

• Iseral- The July 24^th draft meeting minutes were provided to the committee; calls for edits or draft changes to the minutes
• Iseral- Requests motion to approve the DURB meeting minutes as presented- motion carries
• Kudisch- Recommendations from the July 2026 board meeting have been approved and posted to the website

 

Agenda item 4: Public comment and discussion on the drug classes to be reviewed for the Medicaid Preferred Drug List (PDL)

• Iseral- Reads public comment announcement
• Item 4a- androgenic agents, topical; no public comment
• Item 4b- antibiotics, gastrointestinal (GI)

 Eva Preisner, Nestlé Health Science

• Vowst is the first and only FDA approved orally administered microbiota-based therapeutic comprised of pharmaceutics spores; made to reduce recurrent clusters difficile infection (rCDI)
• Limitation of uses is not indicated for the treatment of CDI; risk increases to 40%
• Recurrent infections are a challenge that antibiotics don’t always manage
• CDI recurrences are estimated to contribute up to 2.8 B of the total 5.4 B annual treatment costs; treating all eligible patients with Vowst offers the greatest cost savings
• 3 publications have supported the use of microbiota therapeutics earlier in the treatment cycle; recent analysis found similar patterns of microbiome disruptions in both groups
• Asks that Vowst remains available
• Item 4c- antibiotics, topical; no public comment
• Item 4d- antibiotics vaginal; no public comment
• Item 4e- anticonvulsants

Jordan Smelley, Self

• Epidiolex requires neither preferred drugless or free for clinical authorization
• Request that board eliminates authority of MCOs to independently implement clinical prior authorization requirements approved by the board
• Texans have no say whether they are free for service or managed care; limited say to MCOs
• Item 4f- antiemetic-antivertigo agents (excludes injectables); Erica Scott submitted written testimony
• Item 4g- antifungals, oral; no public comment
• Item 4h- antifungals, topical; no public comment
• Item 4i- antihistamines, first generation; no public comment
• Item 4j- antiparasitic, topical; no public comment
• Item 4k- antivirals, topical; no public comment
• Item 4l- bone resorption suppression and related agents

 

Brock Bizzell, Medical Value and Access Liaison, Amgen

• Asks board to consider preferred access to Evenity, for postmenopausal women with osteoporosis at a high risk of fracture and for those an anabolic treatment is medically appropriate
• Treatment is limited to 12 monthly doses; recent position statements say that osteoporosis treatment should be individualized
• Phase 3b structure trial revealed a group difference of 3.2 percentage points between Evenity and Teriparatide
• Evenity carries a box warning of cardiac complications
• Item 4m- colony stimulating factors; no public comment
• Item 4n- epinephrine

Tricia Wallace, ARS Pharmaceuticals

• Appreciates open access to Neffy, the epinephrine nasal spray for type one allergic reactions, including anaphylaxis in adult and pediatric patients
• Anaphylactic event can turn deadly without epinephrine

 

Sydney Greenberger, Advocacy and Policy Coordinator, Asthma and Allergy Foundation of America (AAFA)

• AAFA supports Medicaid preferred drug lists, including needle free epinephrine forms for patients at risk of anaphylaxis
• Epinephrine is the only option for severe allergic reactions, needle-free form is essential

 

Nissa Shaffi, Head of Policy and Advocacy, Allergy and Asthma Network

• Epinephrin is the only first line treatment; reiterates importance of immediate treatment
• Appreciates that Neffy removes the psychological barrier of a needle
• Item 4o- GI motility, chronic; no public comment
• Item 4p- growth hormone

 

Sejal Upadhyaya, Medical Account Director, Novo Nordisk

• Supports R&D portfolio
• Sogroya is a once weekly, long-acting growth hormone for pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone
• Informs of updated label indication that includes three new pediatric indications for patients 3.5 years and older
• In a global phase 3 program, Sogroya met primary end points of annualized height velocity at one year and demonstrated non-inferior growth hormone outcomes compared with daily therapy
• Most common adverse reaction in children was nasal laryngitis

 

Andrew Howe, PharmD, Ascendis Pharma

• SKYTROFA treats patients with growth hormone deficiencies, and is a once weekly long-acting growth hormone designed to release unmodified somatropin
• Medicaid patients have suboptimal adherence rates of 41% after 12 to 36 months respectively
• Long term extension data during the enlighten trial showed sustained improvements in the mean height standard deviation scores
• In adults, SKYTROFA showed improvements in body composition versus placebo including reduction in trunk percent fat; reduction in injection site reactions

 

Tyler Gums, Payer Accounts Medical Lead, Pfizer

• Asks that Ngenla, a human growth hormone for pediatric patients with growth failure, be added to the preferred drug list
• Ngenla is administered subcutaneously weekly and comes in a multidose single patient use disposable pre-filled pen
• 52 weeks of treatment resulted in the annualized height velocity of 10.1 cm per year; secondary endpoint
• Item 4q- hepatitis C agents; no public comment
• Item 4r- HIV/AIDS

 

Betty Lee, Medical Value and Evidence Liaison, Gilead Sciences

• Thanks for continued efforts to AIDS and HIV
• HIV patients are living longer and aging; dhhs recognizes treatment optimization
• BIXLENVO, once daily oral treatment for virologically suppressed adults with HIV
• BIXLENVO is a combination of bictegravir and lenacapavir in a single tablet
• Artistry trials focused on individuals with complex HIV regiments; phase 3 artistry program revealed viral suppression in 96% of participants who switched from a complex regiment
• Item 4s- hypoglycemics, incretin enhancer agents and amylin analogs; no public comment
• Item 4t- hypoglycemics incretin mimetic agents

 

Jordan Smelley

• Requests adding 4 yes/no questions to the prior authorization criteria:
• 1) Was a formulary exception request submitted?
• 2) Is the medication being prescribed off label for a rare genetic disorder or a manifestation of that condition?
• 3) Is there a FDA approved medication for the patient?
• 4) Has the prescribed provider provided documentation supporting medical necessity?
• Shares personal anecdote as a patient with a rare genetic disorder; we need to hold MCOs accountable
• Vanek- Thank you for your testimony, we will take these issues into consideration

 

Christopher Rios, UCSF 4^th Year Medical Student

• Speaking for research team from HOPE lab; group studies diabetes drugs throughout the country
• For the PDL, board may want to keep at least one preferred GLP with proven outcome benefits
• Appreciates pending revisions to try oral drug firsts; however, requirements are stricter for patient with diabetes
• Thyroid cancer threat, kidney failure threat GLT2 criteria
• Board could consider limiting the thyroid exclusion to the conditions in the box warning

 

Elizabeth Lubelczyk, Payer Health Outcomes Liaison, Eli Lily and Company

• Tirzepatide, a dual GLP, GLP1 receptor antagonist marketed as Mounjaro and Zepbound, is to improve glycemic control for adults and pediatric patients with type 2 diabetes
• In August, FDA approved Mounjaro to help with cardiovascular events in adults with type 2 diabetes
• Phase 3 surpass program evaluated tirzeptaide across the treatment and against comparators; showed robust and consistent reductions in A1c and body weight
• Clinical guidelines recommend treating obesity in patients with obstructive sleep apnea; Surmount USA comprised 2 trials
• More than half of CPAP patients stop within a year; for both products the safety profile is consistent

 

Richard Easom, Medical Liaison, Novo Nordik

• Type 2 diabetes is a cardiometabolic disease that elevates risk of heart attack and stroke and failure
• Clinical guidelines recommend prioritizing therapies that address downstream complications
• Ozempic injections are the only diabetes GLP-1 with 3 FDA improved indications; glycemic controls, reducing the risk of MHAS, and risk of sustained kidney disease and death
• Kidney failure is one of the most clinically and financially costly complication
• 14% reduction in MHAS
• Ozempic injection tablet offers protection against the most serious complications; refers committee to full prescribing information
• Asks that DRUB adds and maintains Ozempic tablets and injections in the preferred drug list
• Item 4u, hypoglycemics, insulin and related

Milli Vakharia, Medical Science Liaison, Mannkind Corporation

• OPHRESA is an insulin inhalation powder for people with diabetes, now approved for adolescents; adolescents are one of the most vulnerable groups in diabetes care
• OPHRESA allows for more flexible correction dosage with less dose overlap
• In Phase 3 inhale 1 pediatrics study, OPHRESA showed similar glucose control compared to the injectable
• No new safety findings; patients and caregivers reported high satisfaction with outcomes

 

Thomas Blevins, Endocrinologist

• Has investigated clinical trials on insulin; recommends inhaled insulin be included as a rapid acting insulin option for pediatric and adult patients
• Has done clinical trials with MannKind who released OPHRESA
• Reiterates that inhaled insulin is as effective as injected insulin
• Kubes- Could you tell me about dosing errors associated with the inhaled? How is it dialed to get whatever dose?
  • There are three doses; it does take knowledge to know how to convert from rapid action insulin but there is a simple formula
  • Patients learn how to use it too
• Kubes- I work in pediatrics, having a non-injectable formulation may increase adherence; do you have any experience using it with CGM?
  • Yes absolutely; CGM really helps
• Kubes- What type of long-acting insulins do you normally see mixed with it?
  • I like to use degludec or U300 because they are so flat
• Item 4v- Hypoglycemics, meglitinides; no public comment
• Item 4w-Hypoglycemics, metformin; no public comment
• Item 4x-Hypoglycemics, SGLT2

Christopher Rios, UCSF 4^th Year Medical Student

• Discusses Dapagliflozin, a SGLT2 inhibitor
• Clinical practice guidelines recommend SGLT2 inhibitors because they reduce death and cardiovascular complications; for people with chronic kidney disease, dapagliflozin reduced kidney failure and death
• Pricing has changed this year; pharmacies now pay $6 a month; the brand name version is $178 a month
• We don’t know the savings that the generic would bring to Texas; recommends making generic dapagliflozin a preferred drug as the generic price settles or removing the clinical prior authorization; main tradeoff would be an administrative check
• Item 4y- hypoglycemics, tzd; no public comment
• Item 4z- IgA nephropathy

 

Brad Harrison, Managed Market Liaison, Otsuka Pharmaceuticals

• VOYXACT, known as sibeprenlimab-szsi, received accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression
• Available in a 400 mg self-administered subcutaneous injection every 4 weeks; VOYXACT is an April inhibitor
• Immature proteinuria is typically diagnosed at 20 to 40 years old and a strong predictor of kidney decline
• Phase 3 visionary trial evaluated over 500 patients; placebo adjusted reduction of 51.2%; most adverse events were mild and moderate

 

Luis Velez, Nephrologist

• Requests that sibeprenlimab is left on the preferred drug list
• Currently has 20 patients with IgA; follows protein excretion and EGFR decline
• CKD aspect should be looked at; immune modulating is new and important
• Reduced abnormal IGA by about 70%; data shoes stabilization of EGFR in these patients

 

Kristen Duffey, Value Evidence Lead, Novartis

• Fabhalta, iptacopan, is an oral factor B inhibitor that slows down kidney decline in adults with primary IgA nephropathy
• Dosed at 200mg, twice daily
• Importance of specific drivers in kidney injuries; available therapies act at different points
• Clinical relevance of targeting pathway is supported by the phase 3 study; annual rate of EGFR decline of 3.5 mills per minute
• Long term safety findings were consistent with safety profile
• Item 4aa- macrolides-ketolides; no public comment
• Item 4bb- opiate dependence treatments

Kenneth Berry, Alkermes

• Thanks for continued support for patient withdrawal

 

Nick Casale, Indivior Pharmaceuticals

• Indivior manufactures suboxone and sublocade which is an extended-release injection
• Discrepancies in the therapeutic class review by Gainwell; updates that occurred to the sublocade labeling was not reflected in the opioid dependence treatments overview
• Sublocade no longer requires a dose adjustment period with sublingual apomorphine; previously required a seven day run in
• FDA allowed for a single test dose and 300 mg after test dose is observed
• Asks that sublocade be moved to the preferred drug list; is part of PDL in 45 other states
• Kubes- You mentioned going from a clinic administered med to a preferred drug list; how do we make that happen if there have been changes in dosing administrative?
• Kubes- These are patient access issues if this is restricted
  • (HHS Employee) Nahid Assadi, HHS- This is related to how we add drug products to our formulary for outpatient pharmacy benefits; we use information from drug packet insert; if specification has been removed, we can revisit that product
• Kubes- Nick, is this a change in the package insert?
  • Casale- Because of how the drug is administered, patients are not allowed to self-inject; can also be administered at pharmacies
• Kubes- Sounds like the drugs our surgeons will inject for precocious puberty
  • Casale- Some MCOs cover it under pharmacy benefits
• Kubes- Can you comment on the difference from a cost perspective?
  • Casale- The drug is not ultra-high cost; since we’ve launched drug went out to over 500k patients
• Item 4cc- tetracyclines; no public comment

 

Agenda item 5: Public comment and discussion on single new drugs to be reviewed for the Medicaid PDL

• Item 5a- arynta, stimulants and related agents

James Anderson, Austin Regional Clinic

• Pediatrician with patients who have ADHD; requests that Arynta lisdexamfetamine oral solution be added as a preferred ADHD medication
• Lisdexamfetamine is my preferred stimulant; does not contain immediate release component and uses a pro-drug mechanism of action
• Arynta has had a consistent clinical response and offers dosing flexibility; dye free liquid and flavorless
• Liquid formulation allows for closer titrate and optimal dosage; younger patients and patients with developmental disorders prefer this

 

Jordan Smelley

• This is another category that falls under the same issue with Epidiolex
• Board needs to ensure equal access to medication
• Kubes- Is there a specific drug that you’re mentioning?
  • Arynta

 

Jose Estrada, Medical Science Liaison, Azurity Pharmaceuticals

• Supports review of Arynta
• ADHD is a common and complex neurodevelopment disorder
• For full review of indications, review the product information; liquid formulation is what makes Arynta special
• Kubes- Can you comment on Arynta versus the chewable Vyvanse?
  • Texture sensitivity, precision dosing, and other factors can impact that choice
• Item 5b- baxfendy, antihypertensives

 

Randy Ferreter, Medical Affairs Department, AstraZeneca

• Supports review of Baxfendy for the treatment of patients with high blood pressure who are not controlled on other agents
• Hypertension is the most modifiable cardiovascular risk factor; every 10mm of mercury reduction reduced risk of vents and stroke by 20%
• Baxfendy is dosed at 2mg orally once daily; unique as the first aldosterone synthase inhibitor
• Does not inhibit sex hormones
• Clinical trials revealed double digit drops in blood pressure; recommends Baxfendy be added to PDL
• Item 5c- Jakafi XR, oncology, oral-hematologic; no public testimony
• Item 5d- Lifyorli, oncology, oral-other

 

Puru Lamichhane, Corcept Therapeutics

• Lifyorli is an NFD approved treatment for adult patients with ovarian, fallopian tube or primary peritoneal cancer who have received treatment regiments
• Ovarian cancer is common in the U.S. and most patients experience a recurrence
• All the recently approved benefits may benefit biomarker populations; GR is expressed in tumor and immune cells
• Lifyorli is a receptor that inhibits activists in the GR pathway and enhances induced aptosis in pre-clinical studies; reduces risk of progression or death by 30%
• Item 5e- multaq, antiarrhythmics agents; no public comment
• Item 5f- quivigy, immune globulins; no public comment
• Item 5g- rezdiffra, thyroid hormone agonist agents

 

David Victor, Gastroenterologist in Transplant Hepatology

• Rezdiffra is the first thyroid beta receptor agonist that’s approved for MASH with hepatic fibrosis
• Medicine is an effective therapy for patients with F2 to F3 fibrosis identified on non-invasive testing
• This is a true epidemic problem; medicine is a unique mechanism that is directly anti-fibrotic to the liver

 

Tara McKinley, Health Systems Director, Madrigal Pharmaceuticals

• Brief overview of MASH and rezdiffra, an orally active liver directed thyroid beta receptor agonist
• MASH is a progressive serious liver disease, characterized by inflammation and worsened fibrosis; can result in liver transplant or death
• Fibrosis stage is an important prognostic factor; trial for rezdiffra achieved statistically significant improvements
• Deshpande- Curious about the specificity of the drug only impacting the thyroid receptor at the liver
  • It has high affinity for THR beta; liver targeted and little effects outside of it
• Victor- The thyroid receptor beta is liver specific; has used this medicine successfully without side effects
• Item 5h-saphnelo pen and syringe, immunosuppressives; no public comment
• Item 5i-veozah, menopausal agents; no public comment
• Item 5j- zepbound, sleep apnae agents, injectables

 

Jordan Smelley

• Asks that board maintains access to four pen and not just Kwik pen; is deathly allergic to Kwik pen
• Zepbound has helped me tremendously; reiterates importance of exceptions for rare genetic disorders
• Kubes- Thank you Jordan for keeping us updated on your progress
• Item 5k- zolymbus, opthalmics, glaucoma agents; no public comment

 

Agenda item 6: Therapeutic and clinical drug reviews, updates, discussion, and recommendations: Gainwell Technologies and DURB members

 

Dr. Shu-Wen Tran, Clinical Pharmacist, Gainwell Technologies

• First 4 classes do not have any updates: 1) androgenic agents, topical, 2) antibiotics, gastrointestinal, 3) antibiotics topical, 4) antibiotics vaginal
• The following generic anticonvulsants are available on the market: briviact, spritam, eprontia
• FDA has approved a new molecular entity named nereus; an oral neurokinin-1 inhibitor to prevent vomiting induced by motion in adults
• Granisol solution was previously discontinued but has now been released back in the market
• FDA has expanded Noxafils treatment to now include pediatric patients of at least two years of age
• On antifungal, topical treatments, Generic Ecoza is now available
• Following five classes do not have updates: 1) antihistamines, first generation, 2) antiparasitics, topical, 3) antivirals, topical, 4) bone resorption, suppression, and related agents, 5) colony stimulating factors
• No further updates on Neffy
• FDA has expanded two indications for Linzess, now includes pediatric patients 2 years and older for functional constipation and 7 years and older for IBS and constipation
• 2 drug classes do not have any updates; growth hormone and hepatitis c agents
• FDA has approved new drug known as Idvynso, a two-drug combination tablet for a complete HIV regiment treatment
• Generic etravirine tablets are available
• Generic Qtern is now available
• Deshpande- Let’s look at our PA criteria in that category; with respect to the comments from the presenters to align criteria around the thyroid cancer exclusion
• FDA has changed name from Rybelsus to Ozempic tablets
• Wang- Aligning PA criteria with thyroid cancer is important
• Vanek- Can we go back to HIV class again? Is the new medication Bixlenvo going to be discussed?
  • That is not in the docket to review today; we will follow up with you offline
• Vanek- We should align criteria for GLP-1s
• No further for Ophresa
• Vanek- Should there be a formula exception for rare genetic disorders?
• Refers to VDP
• Kubes- Seconds Vanek
• Vanek- Where should we discuss this?
  • Assadi- We will take this into consideration and get back to you
• Wang- What is being done to align CAM vs outpatient benefit formulary?
• Vanek- Has had patients where that doesn’t align for them either
  • Assadi- We will take that into consideration
• Deshpande- Can we get a specific update in the next meeting? We have noted the issues between the two formularies in past meeting
• Kubes- Suggests that the board helps with that alignment
• Next 4 drug classes do not have any updates; 1) hypoglycemics, meglitinides 2) hypoglycemics, metformin, 3) hypoglycemics SGLT2, 4) hypoglycemics TZD
• Deshpande- Regarding SGLT2 class and alignment, recommends that generic Dapagliflozin be on the preferred list and we should remove the PA criteria for that drug class
• IgA nephropathy is a new PDL class; currently there six different molecular entities to treat IgA but today’s update focuses on 5
• Tarpeyo is an oral once daily corticosteroid to treat nephropathy for those at risk with disease progression
• Filspari is an oral once daily endothelin and receptor antagonist to slow kidney function decline and to reduce proteinuria for adult and pediatric patients aged 8 and older
• Vanrafia is an oral once daily endothelium receptor antagonist to reduce proteinuria in adults with primary IGA nephropathy
• No further additions for Fabhalta or Voyxact
• Kubes- You made a comment about Vanrafia, does that preclude it from being a preferred drug?
  • We are reviewing that today
• No updates for the remaining three classes: 1) macrolides-ketolides 2) opiate dependence treatments 3) tetracyclines
• Updates for single class reviews:
• No further updates for Arynta, Baxfendy, Jakafi XR, Lifyorli
• Kubes- When I reviewed the PDL for Arynta there are only two solution options that are not this specific problem; more liquid options should be a goal
• Multaq is newly added to PDL and helps reduce the risk of hospitalization for atrial fibrillation and adult’s inpatient with sinus rhythms
• Kubes- It looks like Multaq was approved in 2009, is there a reason why it wasn’t reviewed prior
  • Luong- When we review drugs for PDL it could stem from other drugs in the market; that’s why we have new agents
• Kubes- So this wasn’t available on PDL prior to this
  • Luong- It could have been, but we are reviewing it as a single new drug
• FDA has approved Qivigy to treat adults who have primary humoral immuno deficiency
• No further comments for Rezdiffra
• Two new dosage formulations for Saphnelo, now available in a prefilled syringe, previously was only available through IV infusion
• Veozah is a newly added drug to PDL for moderate to severe motor symptoms due to menopause
• Kubes- Happy to see this drug to review and menopausal symptom drug
• No updates for Zepbound
• Vanek- Wanted to follow up with the comment made by Mr. Smelley
  • There’s two formulas for Zepbound; pen and Kwikpen
• Vanek- He has an allergy to the Kwik pen, how would someone who is allergic to one have access to the other?
• Kubes- One of it has phenol, which he is allergic to; Dr.Vanek is asking how he can get the formulation he is not allergic to
  • Luong- Both are available, being reviewed for PDL status now
• Vanek- That will solve issue for our formulary, but his issues were with the MCO
  • Luong- Our MCOs follow one formulary, it has to be consistent
• Wang- So there is one formulary for the state, but criteria vary for MCOs
  • Luong- Not for the Zepbound, clinical authorization is mandatory; there is optional and mandatory
• Kubes- What are the differences you can see between services?
  • Deshpande-certain drugs have mandatory prior authorizations that must be followed; emphasizes that quote optional authorizations must be reviewed; optional authorization is for certain instances
• Sprenger- And optional criteria cannot be stricter than what we are approving
• Assadi- Search engine or page for formulary search reflects clinical prior authorization for fee for service patients
• Wang- I have noticed this and this is a point of confusion; we could optimize this resource and clarify
• FDA has approved Zolymbus now available as a preservative free ophthalmic gel

 

Agenda item 7: Executive Work Session

• Isarel- We do not have quorum; we can hear presentations but not take any action

 

Agenda item 8: Announcements of drugs recommended for the Medicaid PDL: Optum Rx

 

Dr. Rob Earnest, Optum Rx

• First therapeutic category is the androgenic agent, topical; recommendations are to move testosterone transdermal authorized gel tube, (testim, vogelxo) from preferred to not preferred
• No recommendations for 1) antibiotics, gastrointestinal, 2) antibiotics, topical, 3) antibiotics topical vaginal, 4) anti-convulsant
• Recommends adding granisol and nereus as non-preferred products to the PDL; sancuso to prefered
• For antifungal orals, recommends adding vfend and posaconazole to non-preferred; and adding posaconazole oral and generic to preferred
• For antifungals, topicals, recommends adding lasolex and tritolnacide to non-preferred
• For antihistamines, recommends moving carbinoxamine oral tablets and liquid to non-ppreferred
• For antivirals topical, recommends moving acyclovir generic cream to non-preferred and acyclovir topical cream to preferred
• For bone resorption suppression and related agents, recommends adding risedronate sodium oral tablets to preferred
• For colony stimulating factors, recommends adding nivestym vial and syringe to non-preferred and granix vial/neupogen syringe and vial to the preferred list
• For epinephrine products, recommends moving generic epipen and epipen jr to not preferred
• For GI motility chronic, recommends moving prucalopride tablet to preferred
• For growth hormone, recommends moving somavert vial to preferred
• For hepatitics C agents, recommends adding vemlidy to preferred
• For HIV/AIDS, recommends idvynso tablet to preferred
• For hypoglycemics, incretin enhancer agents and amylin analogs, recomends zituvimet tablet and TBMP to not preferred
• For hypoglycemics, incretin mimetic agents, recommends adding ozempic oral tablet to non-preferred and mounjaro pen injector to preferred
• For hypoglycemics, insulin, and related agents, recommends adding insulin lispro vial, novolog vial, pen and cartridge to not preferred
• For hypoglycemics, insulin, and related agents, recommends adding basaglar kwikpen, jumulin kwikpen, insulin lispro protamine mix pen, lyumjec kwikpen, and merilog vial to preferred
• Also adding merilog solostar, novolin flexpen, semglee vial and insulin pen to preferred
• For hypoglycemics SGLT2, recommends adding dapagliflozin tablet, steglatro tablet to the preferred list; farxiga to the non-preferred list
• For hypoglycemics TZD, recommends moving pioglitazone-metformin tablet to preferred
• For the IgA nephropathy, recommends adding fabhalta, filspari and tarpeyo to preferred; mobing vanfaria and voyxact to non-preferred
• For opiate dependence treatments, recommends adding rezenopy nasal spray to preferred list
• For tetracyclines, recommends moving morgidox to not preferred
• For single new drug reviews, recommends adding Jakafi, Lifyorli, and Multaq to the preferred list; and arynta, baxfendy and qivigy to the non-preferred list
• Also recommends adding rezdiffra, veozah, and zepbound to the preferred list; saphnelo syringe and pen injection and zolymbus droper gel to non-preferred
• Kudisch- Motion to approve recommendations by Dr. Earnest for the PDL- motion carries

 

Agenda item 9: Prospective prior authorization proposals: Acentra Health

• Kudisch- We will vote on these items individually

 

Dr. Lauren Morgan, Acentra Health

• DURB approved CPAs are available for MCOs and FFS to implement; required CPAs include hormonal therapy agents, promethazine agents, wegovy and zepbound
• Today we will go over lynavoy, alkindi sprinkle, lipfendra, trutakna, saphnelo, brinsupri and vtama
• Item 9a- Lynavoy is for cholestatic pruritus treatment associated with PBC in adults; dose less than 80mg a day
• Motion to approve recommended proposal for biliary cholangitis agents- item 9a
• Deshpande- Why do we need prior authorization for this drug?
  • Assadi- Unsure of source but it is the general process
• Kubes- Agrees
• Deshpande- This could be administratively burdensome to the provider
• Kubes- If we don’t agree that it needs clinical preauthorization, how do we go about that?
  • Assadi- It could be voted down
• Kudisch- Given there’s no motion we’ll continue to item 9b
• Item 9b- buprenorphine and naloxone are maintenance treatment of opioid dependence; age check, diagnosis check and intolerance to naloxone
• Updates to remove check for a diagnosis of pregnancy
• Kudisch- Motion to approve item 9b- motion carries
• Alkindi Sprinkle is a replacement therapy for pediatric patients with adrenocortical insufficiency; proposed criteria is an age check and diagnosis of insufficiency
• Kubes- What is the specific diagnosis of adrenocortical insufficiency?
  • Assadi- A25.0 is the code for disorders with enzyme deficiency
  • Morgan- You can see supporting table with the codes
• Kubes- We use hydrocortisone at tiny doses for NICU babies; this would be considered a secondary, advocates for a new adrenal insufficiency
  • Morgan- Table does have 7 ICD codes; are there othes you think should be added or just remove the check?
• Kubes- Unsure if this needs clinical criteria for this; pediatric patients will only need tiny doses
• Assadi- Which medication did you refer to when you mentioned compounding? Are the ones being reviewed being used for that purpose?
  • Kubes- We’re talking about Elkin, it is hydrocortisone; general practice is to compound it
• Deshpande- Also comfortable with not having PA; we can consider in the future if necessary
• Crenessity is an adjunctive treatment for glucocorticoid replacement to control androgens in adults and pediatric patients with congenital adrenal hyperplasia (CAH); criteria will check for concurrent therapy with glucocorticoids, renal impairment, dose check
• Deshpande- Doesn’t think a PA is necessary here
  • Morgan- This one could contribute to cost savings
• Deshpande- Fair but this is not a drug that would be prescribed without indication
• Kubes- Agrees; what is this specific medication going to provide that steroids alone, don’t?
• Deshpande- Allows for a lower dose for a long-term; outcomes with bones
• Kubes- Would this be a specialty drug?
  • Morgan- Unsure but will get back with answer
• Kubes- Agrees with PA on this one
• Deshpande- Only conventional therapy is steroids; if you have this diagnosis, you’re eligible for this drug
• Kudisch- Without a motion, let’s move on to item 9d
• Lipfendra is adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia including HeFH
• First oral PCS inhibitor; renewal approval criteria will check for clinical response to Lipfendria therapy and dosage
• Kubes- Question on the renewal; if they don’t have a 40% reduction, will it be approved?
  • Morgan- If they don’t meet that, they will not be approved; in trials, there was a reduction of 56-59%
• Kubes- Since when have we checked efficacy?
  • Morgan- We do for all of them
• Kubes- I just think it’s restrictive
  • Morgan- If you want to remove that check, we will need to do that across the board
• Kubes- Everyone metabolizes things differently, asks for input
• Deshpande- Over what period of time do we want to see that 40% decrease?
  • Morgan- A year later at renewal; week 24 showed decrease in the trial
• Kubes- Do you have your baseline number prior to therapy and then the 40% gets calculated
  • Morgan- It would be from the baseline
• Kudisch- Motion to approve item 9d- motion carries
• Trutakna is a treatment to reduce proteinuria in adults with primary IgAN at risk for disease progression; approved criteria will check for age, diagnosis and concurrent therapy with a RAS inhibitor

Dr. Paul Cockrum, Health Outcomes Liaison, Vera Therapeutics

• IgAN is associated with significant economic and long-term health burdens that escalate with kidney failure; requires simultaneous management
• Requests adding coverage for Trutakna for Texas Medicaid patients

 

Kristen Duffey, Value Evidence Lead, Novartis

• Vanrafia is a selected endothelin A receptor antagonist taken orally as a 5mg tablet once daily; indicated to reduce proteinuria in adults with primary nephropathy
• Aligned trial enrolled patients with proteinuria of one gram per day; understanding of risk has now evolved
• Novartis requests that prior authorization criteria for vanrafia keep clinical discretion around UPCR threshold, and that additional step therapy is not required when deemed appropriate
• Kubes- Which medication are we specifically discussing?
• Kudisch- going back to the presentation
• Vanrafia is meant to reduce proteinuria in adults with primary IgAN at risk of rapid progression, generally a urine protein-to-creatinine ratio; approval criteria will check for age, pregnancy, concurrent therapy and no diagnosis of hepatic impairment
• Deshpande- In this category of agents for IgA nephropathy, is there a check for whether a patient is taking another one of these particular agents?
  • Morgan- There is not, would you like to propose a check?
• Deshpande- That would be valuable
  • Morgan- And this is for the guide across the board?
• Deshpande- Yes in this category of agents
• Kubes- So we’re focused on vanrafia; the health outcomes liaison mentioned individuals at risk for worse outcomes, could you phrase it as clinically significant protein area despite optimized care?
  • Morgan- In the proposed criteria there is not a check for the UPCR
• Voyxact is indicated to reduce proteinuria in adults with primary IgAN at risk for disease progression; approval criteria include age check, diagnosis, concurrent therapy with a RAS inhibitor and dosage
• Kubes- What if they’re on RAS therapy but couldn’t tolerate it?
  • Morgan- We could add a check for intolerance; it was just studied with RAS inhibitors
• Kubes- I would propose that, likes the flexibility
  • Morgan- And that would be across the board
• The first change is to add a check for no duplicate therapy and to add an option if the patient has a contraindication or intolerance to the inhibitor
• Kudisch- Motion to approve item 9e with the recommended changes by Dr. Deshpande and Dr. Kubes- motion carries
• Saphenlo is indicated to treat adult patients with moderate to severe systemic lupus erythematosus (SLE) who receive standard therapy; approval criteria check for age, diagnosis, concurrent use with SLE therapy, and dosage check
• Kubes- Is there any data with pregnant women on this drug?
  • Morgan- Not to my knowledge
  • Holmes- There’s no data studies on pregnancy; we use it based on risk vs benefit
• Kudisch- Motion to approve 9f as presented- motion carries
• Brinsupri is for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients; approval criteria checks for age, diagnosis, and no cystic fibrosis
• Kubes- Is there a reapproval criteria?
  • Morgan- No there is not

Sherry Andes, Medical Outcome Liaison, Insmed Incorporated

• Insmed supports clinical pre-authorization for brinsupri and access to treatment for patients with NCFB
• Kubes- Since there are no reapproval or renewal criteria, how does that work?
  • Morgan- Initial approval is for a year; they can apply under same criteria for another year
• Kubes- Thinking about consistency and approvals; feels weird to be selective, should be standardized
• Kudisch- Motion to approve 9g- motion carries
• Vtama is for the treatment of plaque psoriasis in adults and topical treatment of atopic dermatitis in adults and pediatric patients; approval criteria includes an age check
• Kubes- Would we use it as a first line agent?
  • Morgan- You could use topical steroids but we’re trying to be package based
• Deshpande- Do we need to have a PA for this?
  • Morgan- This one was recommended by the MCO; checking for age and diagnosis
• Deshpande- Do we want to check if there is another topical being used?
  • Morgan- Okay, yeah
• Kubes- Would they start something else first?
• Kudisch- Motion to approve 9h- motion carries
• Luong- For the record, item 9a and 9c did not go to a vote; are we tabling that criteria?
• Kubes- We don’t think that they need a prior authorization
• Luong- Are we tabling the criteria?
• Kudisch- There is no motion
• Deshpande- Moves to not implement prior authorization for 9a and 9c
• Kudisch- Motion to not implement prior authorization for 9a and 9c- motion carries

 

Item 10: Retrospective drug utilization review (RDUR): Acentra Health

 

 Rachele Poissant, Acentra Health

• RDUR is a federally mandated program for Medicaid programs to evaluate medication use after it is dispensed
• Presentation focuses on fee for service population; MCOs may opt to use same criteria if applicable
• Will review recent interventions, outcome reports and review future interventions that the board will vote on
• Utilization data on the Lasix ONYU product, a subcutaneous furosemide infusion; there has been no utilization of that product
• Interventions have been happening once per month; Antidepressants and mood stabilizers have impacted 316 patients, ADHD intervention supported 120 and SUPPORT Act criteria impacted 153 patients
• First outcome report relates to the management of hypertension and nephorpathy; had 30 patients targeted, and the estimated saving calculation reduced costs by 16%
• Next outcome report relates to overutilization of antibiotics in pediatric patients; 94% change with patients targeted, and a 146% increase in this age range population, $60K estimate
• Report on underutilization of cardiovascular disease treatment, diabetes medications, anticoagulant and antiplatelet therapy had 91 targeted patients; 91% change, estimated cost savings was a reduction of 7% resulting in $21K savings
• 1^st proposal is the asthma management; first criteria is a short-acting beta agonist (SABA) overuse, second is a long-acting beta agonist (LABA) duplicate therapy, third criteria is drug-drug interactions, fourth looks at drug-asthma interactions, last criteria is a Montelukast use without appropriate diagnosis
• Estimates 200 FS patients impacted; 147 being SABA overuse
• Deshpande- These are great and feedback earlier showed good impact; asking to incorporate the MCO population in addition to the FFS population
• Kudisch- Motion to approve item 10ci- motion carries
• Second proposal is the SUPPORT act which monitors standards for the DUR to combat the opioid epidemic; opioid related claims and monitoring antipsychotics use in pediatric patients are two provisions that require RDUR
• Criteria for the SUPPORT act proposal: atypical antipsychotic agent use in pediatric patients, duplicate therapy of short-acting opioids, duplicate therapy of long-acting opioids, MME review of opioid claims, concomitant use of pure opioid agonists and non-benzodiazepine sedatives, concomitant use of opioids and antipsychotic agents, concomitant use of opioids and CNS depressants, use of MAT drugs and opioids, concomitant use of benzodiazepines and opioids,
• Estimates 74 patients impacted in the FFS population; 36 in the atypical antipsychotic agent use
• Kudisch- Motion to approve item 10cii- motion carries
• Last intervention proposal is type 2 diabetes guideline directed care; criteria is no guideline-directed metformin therapy
• Wang- Does this suggest all patients should be on metformin?
  • Poissant- This is specific to patients with diabetes and do not have metformin therapy
• Wang-From recent ADA guidelines, this may not be the case depending on the patient; does not agree with the recommendation everyone should be on metformin
  • Poissant- It’s almost all patients but not every patient requires
• Wang- Refers to ADA guidelines; a lot of patients with diabetes struggle with obesity
• Vanek- Agrees this seems broad; are there any more parameters?
  • Poissant- Board could make recommendations
• Wang- Language needed to narrow it may produce big edits
• Vanek- Agrees
• Wang- If we adjust the inclusion or exclusion criteria then this would be first line for patients
  • Poissant- As long as we have those specifics, we can adjust criteria
• Wang- The ADA has a chart for these conditions to be excluded from these criteria
• So, we will expand the exclusion criteria to the ADA first-line therapies exclusions leading to alternative therapies
• Criteria continued: no guideline-directed antihypertensive therapy, underutilization of diabetes therapy, drug-drug interactions, and drug-renal or liver functions interactions
• Estimates 172 FFS members impacted
• Motion will include changes for the first criteria; criteria 1 will be updated to be inclusive of patients with the diagnosis of type 2 diabetes and excluding patients within the ADA guidelines
• Kudisch- Motion to approve 10iii with changes from Dr. Vanek- motion carries

 

Item 11: Retrospective drug use criteria for outpatient use in Vendor Drug Program

Dr. Justin Pedigo, Pharmacist & Clinical Assistant Professor, UT Austin College of Pharmacy

• Presenting: Retrospective Drug Use Proposals
• Criteria sets include: Anti-diabetic Agents, ADD/ADHD Medications, Glucagon-like Peptide 1 Receptor Agonist, Serotonin 5-HT3 Receptor Antagonists for Nausea and Vomiting, Substance P/Neurokinin 1 Receptor Antagonists
• Item 11a- Anti-diabetics Agents (Oral):
• Updated oral GLP-1 therapies to include both oral semaglutide formulations, removed references to sotagliflozin throughout criteria set, as product is on not formulary; updated thiazolidinedione heart failure and bone fracture wording to reflect pioglitazone specifically
• Table 2: added generic metformin 625 mg and 750 mg immediate-release tablets and removed metformin extended-release tablets
• Table 4: added sitagliptin
• Table 6: added semaglutide oral tablets and updated table notes indication to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk for these events
• Table 8: removed sotagliflozin and updated table notes to provide additional information about FDA approved indications other than type 2 diabetes
• Table 9: removed glimepiride and glyburide, as they have been discontinued; added glipizide 2.5 mg immediate-release tablets
• Table 10: removed brand name pioglitazone
• Table 11: removed dapagliflozin/ metformin 2.5 mg/ 1000 mg tablet, as product is not on formulary, added dapagliflozin/ metformin generic formulations, removed dapagliflozin/ saxagliptin combinations, added generic formulation of dapagliflozin/ saxagliptin 10mg/ 5 mg tablets
• Table 11 continued: removed empagliflozin/ metformin 5mg/ 500 mg tablets, as product is not on formulary
• Table 11 continued: removed pioglitazone/ metformin, as product is not on formulary, removed saxagliptin/ metformin, as product is not on formulary, added sitagliptin/ metformin (Zituvimet & XR) with generic formulations also available, updated table notes to provide additional information
• Table 12: added metformin 500 mg and 750 mg extended released tablets
• Table 13: added canagliflozin
• Table 14: added combination of canagliflozin/ metformin (Invokamet & XR), removed dapagliflozin/ metformin 2.5 mg/ 1000 mg dosage, added generics are available for dapagliflozin/ metformin, removed empagliflozin/ metformin, as product is not approved for pediatric patients; removed empagliflozin/ metformin 5 mg/ 500 mg tablets, as product is not on formulary
• Dosage/Renal Impairment: updated to optimize wording for acarbose, metformin, linagliptin, saxagliptin, sitagliptin, repaglinide, canagliflozin, dapagliflozin, and empagliflozin
• Added renal dosing information for combination of doses
• Dosage/Duplicative Therapy: updated language to address concomitant use of DPP-4 inhibitors with insulin or insulin secretagogues and DPP-4 inhibitors used concomitantly with GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists
• Item 11b- Revised Criteria: ADD/ADHD Disorder Medications
• Table 1: reformatted dosage form for readability, added amphetamine salts, mixed 30 mg extended-released capsules, added generic formulation of amphetamine, added lisdexamfetamine, removed methylphenidate due to product discontinuation with generic formulation available on formulary
• Table 1 continued: removed methylphenidate, clarified dosage frequency throughout table, clarified that 60 mg daily of ER amphetamine salts, mixed were assessed in adults during clinical trials, added table note that immediate-release mixed amphetamine salts and methylphenidate ER capsules are used off-label in the management of the ADHD in adults
• Table 2: clarified dosage frequency throughout table
• Table 3: added clonidine ER tablets and clonidine ER oral suspension, added table note to clarify that clonidine ER and guanfacine ER are used off-label to manage ADHD in adults
• Table 4: dosing updated for amphetamine salts, dextroamphetamine, methylphenidate to reflect most recent update of the “Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health”, removed amphetamine sulfate, dextroamphetamine, methylphenidate, methylphenidate; not on formulary; generic formulations are available
• Table 4 continued: removed methylphenidate due to product discontinuation, generic formulations are available, added lisdexamfetamine oral solution, clarified that 60 mg daily of ER amphetamine salts, mixed were assessed during clinical trials
• Table 6: added clonidine extended-release oral solutions; drug-drug interactions were reviewed and updated using Clinical Pharmacology; references reviewed and updated throughout the criteria set

 

Mindy Christianson, Pharm D & Senior Science Medical Liaison, Collegium Pharmaceutical Inc.

• I am here to provide support of the clinical benefits of Jornay PM, which are scheduled for patients with ADHD 6 years and older
• Jornay PM is the only stimulant currently approved for evening dosing; has shown efficiency throughout awakening, the day, and into the evening
• As indicated by its efficiency, Jornay PM has demonstrated it has the potential to control symptoms across a full day for patients with ADHD; the medication’s micro delivery system makes nighttime dosing possible by delaying the release of absorption; less than 5% is released overnight
• Given Jornay’s clinical benefits, we are requesting the committee expand access to Jornay PM for Texas medicated ADHD patients

 

Dr. Justin Pedigo, Pharmacist & Clinical Assistant Professor, UT Austin College of Pharmacy

• Item 11c- Glucagon-Like Peptide 1 Receptor Agonists:
• Dosage/Adults: descriptions of Foundayo and Zepbound were added to the GLP-1 DFA approved indications paragraph, a paragraph with descriptions of insulin/ lixisentide and insulin degludec/ liraglutide was added, updated GLP-1 indications, and updated warnings
• Table 1: updated indications for dulaglutide, liraglutide, semaglutide, tirzepatide, reformatted dosage form for readability, removed exenatide as product is no longer marketed, added generic dosage form of exenatide, added semaglutide 7.2 mg single-dose pen, added Zepbound
• Table 2: updated indications and dosing for semaglutide, added Table 3) adult combination insulin/GLP-1 Agonist Maximum Recommended Dosages, added insulin degludec and liraglutide and glargine and lixisenatide
• Dosage/Pediatrics: added tirzepatide to list of GLP-1 agonists with FDA approvals in pediatric populations 10 years and older
• Table 4: reformatted dosage form for readability, removed exenatide, added tirzepatide, removed table note
• Duplicative Therapy: updated the interactions and wording usage
• Item 11e- Serotonin 5-HT3 Receptor Antagonists for Nausea and Vomiting (oral)
• Dosage/ Adults: updated antiemetic regimes to reflect current ASCO and NCCN guidelines
• Table 1: updated indications for granisetron, removed ondansetron 24 mg tablets, added hepatic dose adjustments, added ondansetron 16mg oral tablets, updated table notes
• Table 2: updated table notes, and updated antiemetic wording to ACSO and NCCN guidelines
• Table 3: added hepatic dose adjustments for ondansetron
• Duration of Therapy: optimized wording to be inclusive of patients of radiation, updated wording, updated drug-drug interactions, ad reviewed and updated throughout criteria set
• Item 11f- Substance P/Neurokinin 1 Receptor Antagonists
• Dosage: removed references to rolapitant as product is not on formulary, updated indication wording for aprepitant and netupitant/ palonosetron to reflect current package insert
• Table 1: added the generic formulations of aprepitant are available, and removed rolapitant
• Table 2: updated indication wording and table notes for aprepitant and netupitant/ palonosetron to reflect current package insert and current ASCO and NCCN recommendations
• Table 3: Pediatrics: updated table notes to reflect current package insert
• Duplicative Therapy: optimized wording to reflect package inserts, updated drug-drug interactions, reviewed and updated throughout the criteria set
• No questions from the board
• Motion to approve Item 11 as indicated by Dr. Pedigo
• Motion carries

 

Item 12: Review of action items for next meeting: January 22, 2027, 9:00am

• No discussion from committee

 

Meeting Adjourned