Specialty Drugs

Use of New Cancer Drugs Without Documented Clinical Benefit Substantially Increases

A growing share of patients have been prescribed oral targeted cancer drugs without documented overall survival (OS) benefit — from 12.7% in 2011 to 58.8% in 2018, according to a JAMA study, which analyzed dispensing claims for oral cancer drugs first approved by the FDA between Jan. 1, 2011, and Dec. 31, 2018. Cumulative spending on all 44 sample drugs reached $3.5 billion by the end of 2018, and 96.8% of that spending was on drugs approved based on a pivotal randomized clinical trial (RCT). Meanwhile, cumulative spending on drugs without documented OS benefit surpassed that on drugs with a documented benefit by the end of 2018. Among the top 20 drugs by spending amounts in 2018, one drug lacked a pivotal RCT and 13 drugs had no documented OS evidence at the time.

Study: Opportunities to Improve Management of PNH Exist

Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare, potentially fatal disease. The FDA approved the first therapy, Alexion Pharmaceuticals, Inc.’s Soliris (eculizumab), a complement C5 inhibitor (C5I), to treat adults with the condition on March 16, 2007. Then the agency approved another C5I to treat adults with PNH from the same company, Ultomiris (ravulizumab-cwvz), on Dec. 21, 2019. A recent study of those two therapies from Prime Therapeutics LLC shows that there may be opportunities for payers in PNH management that will result in better health care outcomes for their members.

Biomarker Testing Is Not Keeping Up With Drug Innovations

Despite the tremendous progress made over the past decade in developing targeted oncolytic therapies, testing for specific mutations —or biomarkers — to determine the proper candidates for those treatments lags behind. A few states have passed or are considering legislation requiring insurers to cover biomarker testing, with California becoming the most recent state to pass such a law.

BCBST, Oncology Group Launch Oncology Medical Home

BlueCross BlueShield of Tennessee (BCBST) and community oncology practice Tennessee Oncology recently launched a value-based cancer care program aimed at providing high-quality, cost-effective health care. The oncology medical home (OMH) will be a model for future programs, says the Blues plan.

The initiative launched in October for BlueCross commercial networks P, S and L members. It will support members beginning with their diagnosis and then through treatment and follow-up care. The partners will work to make sure that best practices in care planning and treatment are followed, that care guidelines are met, that patients get the correct treatment at the right time and that patient-centered care is provided.

New FDA Approvals: FDA Approves Besremi | Dec. 9, 2021

Nov. 12: The FDA approved PharmaEssentia Corp.’s Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with polycythemia vera. It is the first interferon therapy that the agency has approved specifically for the condition. The drug received orphan drug designation for the indication. The recommended starting dose is 100 mcg by subcutaneous injection every two weeks. The dose can be increased by 50 mcg every two weeks up to a maximum of 500 mcg until hematological parameters are stabilized.

News Briefs: Alignment Health Plan will cover Grail’s Galleri liquid biopsy | Dec. 9, 2021

Alignment Health Plan and Grail, LLC signed an agreement that will provide its members access to Galleri, a multicancer early detection blood test. Alignment is a national Medicare Advantage (MA) plan from Alignment Healthcare. The deal makes it the first MA plan to offer the liquid biopsy, which is used as a complement to recommended single cancer screenings and can detect more than 50 types of cancer. It is available by prescription only. New and existing plan members in select HMO and PPO plans in California and North Carolina will have access to Galleri starting Jan. 1.

Studies: Spending on Accelerated Approval Drugs Is Growing Fast

The FDA’s accelerated approval pathway for experimental therapies has been criticized by practitioners and health insurers in recent months following the controversial approval of Alzheimer’s drug Aduhelm (aducanumab). Aduhelm is just the latest of many experimental therapies that has been approved with limited clinical evidence of efficacy — and payers and independent researchers say the FDA should revamp the process to contain costs.

Smaller PBMs Beat Big Firms in Customer Satisfaction

Plan sponsors’ overall satisfaction with their PBMs increased from 8.0 on a 1-10 scale in 2020 to 8.2 in 2021, according to Pharmaceutical Strategies Group’s 2021 Pharmacy Benefit Manager Customer Satisfaction Report. Based on surveys completed by 291 plan sponsors who provide pharmacy benefits to their employees, the report found that PBMs with 20 million or fewer members tend to have higher satisfaction ratings than larger PBMs. Average satisfaction was highest for PBMs’ opioid management programs, while gene therapy financial protection programs rated the lowest and only 13% of the respondents used such programs. Among PBMs with more than 20 million members, MedImpact scored the highest overall satisfaction rate (8.5).

MMIT Reality Check on Colorectal Cancer

A review of market access for colorectal cancer treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions. Around 28% of the lives under Medicare formularies are not covered for at least one of the drugs.


FDA Grants Interchangeable Status to Humira Biosimilar, but Certain Factors May Hamper Its, Other Adalimumabs’ Uptake

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

On Oct. 15, 2021, the FDA granted interchangeability status to Cyltezo for all of its approved uses. Boehringer Ingelheim’s Phase III VOLTAIRE-X clinical trial found no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety over multiple switches between Humira and Cyltezo. Per the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the drug will have one year of exclusivity upon launch during which the FDA cannot grant interchangeable status to another Humira biosimilar.