RADAR on Specialty Pharmacy

New FDA Approvals: FDA Converts Accelerated Approval to Full for Tabrecta

Aug. 10: The FDA converted the accelerated approval for Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) to full approval for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. The agency granted that accelerated approval on May 6, 2020. Dosing of the tablet is 400 mg twice daily. GoodRx lists the price of 112 200 mg tablets as more than $19,667.

Aug. 11: The FDA gave accelerated approval to AstraZeneca and Daiichi Sankyo, Inc.’s Enhertu (fam-trastuzumab deruxtecan-nxki) for adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations as detected by an FDA-approved test (see below briefs) and who have received a prior systemic therapy. This is the first drug that the agency has approved for HER2-mutant NSCLC. The FDA first approved the antibody drug conjugate on Dec. 20, 2019. The drug received priority review and breakthrough therapy designation. Dosing for the newest use is 5.4 mg/kg via intravenous infusion once every three weeks.

Johnson & Johnson Files Lawsuit Against Copay Maximizer Company SaveOnSP

Multiple companies that provide alternate funding options for patients have been launching over the last several years. But one maximizer company has found itself the target of a legal battle with manufacturer Johnson & Johnson over its strategy to reclassify drugs and maximize the copay assistance it gets from pharma manufacturers.

Copay maximizers have companies classify some drugs as “non-essential health benefits” (NEHBs) as outlined in the Affordable Care Act (ACA). They then secure patient assistance for these drugs through manufacturers’ or charitable foundations’ patient assistance programs, taking the full annual amount of assistance per drug and spreading out that money over the course of the year (see story). The programs are seen as follow-on offerings to copay accumulators, which take the maximum assistance up front and deplete the contribution before the end of the year.

Copay Maximizer Programs Are Coming Under Fire

Multiple companies are offering copay maximizer — also known as variable copay — programs. And while they may be attractive to firms that implement them, a closer look might reveal them to be not as appealing as they seem at first blush, say industry experts. The programs also are being challenged in legal settings, including a lawsuit by manufacturer Johnson & Johnson against SaveOnSP (see story).

Traditionally, when a manufacturer provides copay assistance for one of its drugs, that dollar amount would count toward the patient’s deductible and out-of-pocket maximum. But copay maximizer programs will distribute 100% of available manufacturer copay offset funds over 12 months, as opposed to copay accumulators, which apply the maximum manufacturer assistance up front and deplete that contribution before the end of the year. Payments in both approaches do not count toward members’ deductibles and out-of-pocket maximums.

News Briefs: Cancer Replaced Musculoskeletal Conditions as Biggest Driver of Large Companies’ Health Care Costs

Cancer replaced musculoskeletal conditions as the biggest driver of large companies’ health care costs, according to the Business Group on Health’s 2023 Large Employers’ Health Care Strategy and Plan Design Survey. The survey found that “13% of employers said they have seen more late-stage cancers and another 44% anticipate seeing such an increase in the future, likely due to pandemic-related delays in care.” Between May 31, 2022, and July 13, 2022, the organization polled 135 large employers in various sectors that cover more than 18 million people in the U.S. The survey also found that 99% of respondents said that they are concerned about prescription drug trend. Last year, prescription drugs were responsible for a median of 21% of the companies’ health care costs, and specialty drugs accounted for more than half of pharmacy spend.

Survey Finds That Payers Are Covering Sequential Use of SMA Agents

A recent FDA approval of a label expansion put the three marketed therapies for spinal muscular atrophy (SMA) on equal footing for the youngest patients. And recent survey found that many payers are covering sequential use of the costly agents, including a gene therapy.

The FDA initially approved Evrysdi (risdiplam) from Roche Group member Genentech USA, Inc. on Aug. 7, 2020, for the treatment of SMA in people at least 2 months old. On May 30, 2022, the agency expanded the drug’s label to include the treatment of infants less than 2 months old. The survival motor neuron 2 (SMN2) splicing modifier is an oral solution administered by mouth or feeding tube and can be administered by a patient or caregiver at home after a recommended consultation with a health care professional prior to the first dose.

Specialty Trend Rose in 2021, but Biosimilars Are Having Impact

Specialty drug trend in 2021 largely recovered from the hit it took from the COVID-19 pandemic in 2020, driven mainly by an increase in utilization. That’s according to the 2022 Artemetrx State of Specialty Spend and Trend Report from Pharmaceutical Strategies Group (PSG), an EPIC company.

Published in August, the report is sponsored by specialty pharmacy Reliance Rx. Findings are based on an Artemetrx analysis of 73.9 million medical claims and 55.1 million pharmacy claims from PSG’s book of business. It is the sixth annual version of the report.

Industry Expert Maintains That Specialty Pharmacy Market Has Reached ‘Inflection Point’

Multiple trends are occurring within the specialty pharmacy industry that could have a huge impact on the space, maintained longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. Those include greater competition among specialty products, a slowing of payer spending on specialty drugs and more vertical integration among both payers and providers. “We’re at kind of an inflection point in the specialty market,” he contended during the July 29 webinar, titled Specialty Drugs Update: Trends, Controversies, and Outlook.

Medicare Prescription Drug Price Negotiation Is Poised to Become Reality

It appears that for the first time, HHS will be able to negotiate prices of some prescription drugs in Medicare. The pharma industry has long resisted such efforts, and it remains to be seen what the impact of the legislation, if passed, will be on manufacturers’ drug discounts and rebates.
On Aug. 7, the Senate passed the Inflation Reduction Act of 2022 (IRA) 51-50 with Vice President Kamala Harris casting the deciding vote. The House is expected to vote on the bill Friday. If it passes as anticipated, President Joe Biden is projected to sign it into law shortly thereafter.

Payers, Dermatologists Say They Are Interested in New Psoriasis Topicals Vtama, Zoryve

Two new drugs to treat plaque psoriasis are adding to the topical options available to treat the condition. Both payers and dermatologists have expressed interest in the agents, according to Zitter Insights, and the class remains a high priority for payer management.

On May 23, the FDA approved Roivant Sciences subsidiary Dermavant Sciences, Inc.’s Vtama (tapinarof) cream for the topical treatment of plaque psoriasis in adults, regardless of disease severity. The company said the agent is the first and only FDA-approved steroid-free topical medication in its class. Dosing of the aryl hydrocarbon receptor agonist is once daily on affected areas, and the drug has no restrictions on length of use. The price for one tube of the drug is $1,325.

News Briefs: ICER Says Evidence for Beti-Cel Demonstrates Net Health Benefit

The Institute for Clinical and Economic Review (ICER) unanimously determined that evidence for bluebird bio, Inc.’s betibeglogene autotemcel gene therapy “is adequate to demonstrate that the net health benefit of beti-cel is superior to that of standard clinical management,” it said in a final evidence report published July 19. “Given the high costs of standard care, cost-effectiveness modeling finds beti-cel meets commonly accepted value thresholds at an anticipated price of $2.1 million — if that price is subject to an 80% payback for treatment failure,” stated ICER in a press release. The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) unanimously voted in June in support of approval for the treatment of people with beta thalassemia who require regular red blood cell transfusions. The FDA is expected to make a decision on the application by Aug. 19.