Specialty Drugs

Study Suggests Part D Payers’ Prior Authorization Policies for New Drugs May Be Too Strict

Most new drugs covered under Medicare Part D are subject to prior authorization (PA) requirements, largely due to their high launch prices. A recent study published in JAMA Health Forum observed that these policies are frequently inconsistent across payers and may prove too burdensome for patients and providers.

Researchers identified drugs approved between 2013 and 2017 and reviewed the 2020 formularies of the eight largest Part D payers, which cover about 90% of all Part D beneficiaries. They compared PA policies to each drug’s FDA-approved indications and noted if payers mirrored the approved labeling or were more restrictive than the drug’s label. Researchers observed substantial variation in the frequency and type of PA across payers, and they found that about 40% of the new drugs had PA criteria that went beyond the drug’s labeling.

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Gilead’s First-in-Class HIV Drug Sunlenca Offers Much-Needed Option

The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price is below the level that respondents to a Zitter Insights poll said they would consider a good value. The medication comes with both potential advantages and disadvantages for patients, providers and payers, say industry experts.

On Dec. 22, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s) (ARVs), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations.

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Point32Health Exec Says Outcomes-Based Pacts Can Unite Payers, Pharma

While drugs are increasingly hitting the market that address unmet needs and even offer cures for some rare diseases, private insurers are highly concerned about such therapies’ eye-popping price tags, a recent survey indicated. But one prominent payer executive who spoke during AHIP’s Medicare, Medicaid, Duals & Commercial Markets Forum suggested that insurers are better off working collaboratively with drugmakers to ensure prices are tied to value — rather than engaging in an inter-industry war of words.

“More and more we’re seeing drugs come through with limited evidence through accelerated approval processes, which generally is a marker for an unmet need, which is a good thing. But the evidence can be thin,” said Michael Sherman, M.D., executive vice president and chief medical officer of Point32Health. During a March 14 panel at the AHIP forum, Sherman pointed to the example of Makena (hydroxyprogesterone caproate), a drug that aims to reduce preterm births but failed to prove clinical effectiveness in trials conducted after it received accelerated approval. With the FDA poised to make a final decision on the drug’s status, Clovis Pharma Group recently announced it would voluntarily pull Makena off the market.

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FDA Adds CLL/SLL to Brukinsa’s Label

The FDA recently gave an additional approval to BeiGene, Ltd.’s Brukinsa (zanubrutinib), which is already approved for three other rare types of non-Hodgkin lymphoma. Respondents to a Zitter Insights survey said that while its availability will result in a lower level of unmet need in the treatment of chronic lymphocytic leukemia (CLL), there is still moderate or high unmet need for the condition.

On Jan. 19, the FDA expanded the label of Brukinsa to include the treatment of adults with CLL or small lymphocytic lymphoma (SLL). CLL and SLL are the same disease, a type of non-Hodgkin lymphoma, except CLL cancer cells are mostly in the blood and bone marrow, while in SLL, the cells are mainly in the lymph nodes.

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Amid Rising Colorectal Cancer Rates, Young Adults Face Systemic Barriers to Care

A new study published in the Journal of Clinical Oncology found that cancer afflicting adolescents and young adults cost the health care system $23.5 billion in 2021, and $259,324 for the average patient over a lifetime. The findings come as the American Cancer Society reported that incidence of colorectal cancer is becoming more common among that cohort: 20% of new colorectal cancer diagnoses in 2019 were for patients younger than 55, compared with 11% in 1995, per the Wall Street Journal. Experts say that to help, insurers can educate patients and improve access to screenings and care coordination.

Fortunately, the overwhelming majority of adolescents and young adults who are diagnosed with cancer have a positive prognosis: in 2019, the 5-year survival rate for people in that cohort was 85% “with prompt diagnosis and timely delivery of appropriate therapy,” per the Journal of Clinical Oncology study. Approximately 90,000 people ages 15-39 in the U.S. are diagnosed with cancer annually — that’s about 5% of all new cancer cases. The increasing incidence of colorectal cancers contrasts with falling adolescent and young adult death rates “each year between 2010 and 2019,” the study said. Experts say systemic issues make detecting and treating cancers in the adolescent and young adult cohort difficult.

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As Breast Cancer Treatments Continue to Evolve, a Few Stand Out

Breast cancer is the most common cancer diagnosed in American women and the most common cancer globally. Estimates show that more than 300,000 people in the U.S. are expected to be diagnosed this year alone, almost 3,000 of them men.

When the FDA first approved Genentech, Inc.’s Herceptin (trastuzumab) on Sept. 25, 1998, for the treatment of people with breast cancer whose tumors overexpress the human epidermal growth factor receptor-2 (HER2) protein, the drug offered a new targeted approach to treating the disease. In the years since, researchers have identified other subtypes of the cancer and developed newer agents indicated for specific types and stages of the disease.

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News Briefs: FDA Accepted Application for Sanofi’s Biosimilar Denosumab

The FDA accepted its first application for a biosimilar denosumab, Sandoz disclosed on Feb. 6. The Amgen Inc. reference drug is available as both Prolia and Xgeva. According to AmerisourceBergen’s Feb. 6 U.S. Biosimilar Report, nine companies have denosumab biosimilars in clinicals trials, with five of those in Phase III trials. Prolia and Xgeva are approved for multiple conditions, including for the treatment of postmenopausal women with osteoporosis at high risk for fracture and for the prevention of skeletal-related events in people with multiple myeloma and in people with bone metastases from solid tumors. Sandoz’s application is for all of the drugs’ indications. Prolia’s list price is $1,564.31 per injection every six months, and the per-dose price for Xgeva — which is dosed every four weeks — is $2,877.36.

Elevance Health said on Feb. 15 that it had closed its acquisition of BioPlus, a specialty pharmacy subsidiary of CarepathRx, a portfolio company of Nautic Partners. BioPlus will operate as part of CarelonRx, Elevance’s PBM within Carelon, its health care services brand. Elevance said Nov. 9 that it had entered into an agreement to purchase the company. It did not disclose financial terms of the deal. The firm also said that it “plans to expand BioPlus’ service models across more complex disease treatment areas so the combined company can continue to provide timely access to medications, deliver leading support services for both providers and patients, and ensure individuals receive distinctive clinical expertise and service.

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Report Shows Growing Provider Acceptance, Understanding of Biosimilars

The U.S. biosimilars market is a dynamic and ever-evolving space, and a recent report shows growing acceptance of the medications among providers. Last year saw a handful of milestones related to these agents, and this year, particularly with the launches of biosimilars of AbbVie Inc.’s Humira (adalimumab), is likely to continue the trend, according to a recent report from Cardinal Health.

Titled 2023 Biosimilars Report: tracking market expansion and sustainability amidst a shifting industry, the report is based on responses to web-based surveys conducted in 2022 from both community- and hospital-based practices. Providers were from “therapeutic areas with the most potential for disruption in the year ahead.” Cardinal Health polled more than 100 rheumatologists in July and August, 125 dermatologists in September, 70 gastroenterologists in September and October, and 60 retina specialists in September and October.

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New FDA Approvals: FDA Expands Patient Population of Takeda’s Takhzyro

Feb. 3: The FDA expanded the patient population for Takeda’s Takhzyro (lanadelumab-flyo) to include the prevention of hereditary angioedema attacks in people at least 2 years old. The agency initially approved the plasma kallikrein inhibitor on Aug. 3, 2018. Dosing of the subcutaneous injectable in people at least 12 years old is 300 mg every two weeks. In people at least 6 and less than 12, dosing is 150 mg every two weeks, and for people 2 years old and younger than 6, dosing is 150 mg every four weeks. Drugs.com lists the price of one single-dose 300 mg/2 mL subcutaneous solution as more than $26,165.

Feb. 8: The FDA granted another indication to Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept) for the treatment of retinopathy of prematurity in preterm infants. The agency first approved the drug on Nov. 18, 2011. Dosing of the vascular endothelial growth factor (VEGF) inhibitor for the newest indication is 0.4 mg via intravitreal injection; treatment may be given bilaterally on the same day. Injections may be repeated with an interval of at least 10 days. Drugs.com lists the price of a 40 mg/ml intravitreal solution as more than $1,957.

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Gilead’s First-in-Class HIV Drug Sunlenca Offers Much-Needed Option

The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price came below the level that respondents to a Zitter Insights poll said they would consider a good value. The medication comes with both potential advantages and disadvantages for patients, providers and payers, say industry experts.

On Dec. 22, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s) (ARVs), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations.

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© 2024 MMIT