With its Feb. 28 approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) becomes the second chimeric antigen receptor T-cell (CAR-T) therapy to treat multiple myeloma. Payers report being less likely to prefer it over some or all other multiple myeloma treatments with a similar indication, but oncologists are showing more enthusiasm for prescribing the new agent, according to Zitter Insights.

The FDA approved Carvykti for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The product is a B-cell maturation antigen (BCMA)-directed CAR-T agent. The one-time treatment will have a phased launch and will be available through a limited network of certified treatment centers. The FDA gave the drug breakthrough therapy and orphan drug designations. The therapy’s wholesale acquisition cost is $465,000.

To serve patients wanting the ability to refill specialty prescriptions online rather than telephoning a pharmacy, AllianceRx Walgreens Prime launched its digital service offering in late 2019. A recent study of people with multiple sclerosis (MS) revealed similar rates of adherence — measured by proportion of days covered — between people managing their prescriptions via online tools vs. telephonic engagement.

In addition to offering self-serve refill requests, the company “wanted to ensure patients using the digital clinical assessment received the same level of quality clinical care required for a specialty patient compared with patients supported by the traditional telephonic process,” says Sabeen Hasni, R.Ph., director of pharmacy quality at AllianceRx Walgreens Prime and a lead researcher of the study. After patients log in and select specialty drugs to refill, they answer operational and clinical questions specific to their condition, including their response to therapy, on-hand supply of medication and side effects. Algorithms can identify those patients who need additional support from pharmacists, and patients can request to speak with a pharmacist at any time. In addition, providers are notified when their patients trigger an intervention protocol, and pharmacists can contact them to discuss next steps in care.

March 11: The FDA granted an additional indication to AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) for the treatment of people with germline BRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with chemotherapy before or after surgery. The agency first approved the tablet on Dec. 19, 2014. Dosing is 300 mg twice daily. Website Drugs.com lists the price of 60 150 mg tablets as more than $7,778.

March 11: The FDA approved another use for Myriad Genetics, Inc.’s BRACAnalysis CDx test as a companion diagnostic to identify people with germline BRCA-mutated HER2-negative, high-risk early-stage breast cancer who may benefit from Lynparza (see above brief). The test detects and interprets germline BRCA1 and BRCA2 variants. The agency initially approved the test on Dec. 19, 2014.

Medicare will cover monoclonal antibodies targeting amyloid for Alzheimer’s disease treatment that receive traditional FDA approval under coverage with evidence development (CED), according to an April 7 final National Coverage Determination (NCD). In addition, for drugs that have not shown a clinical benefit or that receive accelerated approval, Medicare will cover them in FDA- or National Institutes of Health-approved trials. CMS will cover the medication and any related services for Medicare beneficiaries participating in these trials. The move follows a proposed NCD released Jan.11, which received more than 10,000 stakeholder comments.

Horizon Blue Cross Blue Shield of New Jersey filed a lawsuit (No. 1:22-cv-10493) against Regeneron Pharmaceuticals Inc. regarding Eylea (aflibercept), a medication approved for certain retinal diseases, including wet (neovascular) age-related macular degeneration. The suit alleges that Regeneron transferred funds to the Chronic Disease Fund, which offset patient out-of-pocket costs for Eylea but not its competitors. The lawsuit argues that this is an illegal kickback under the Racketeer Influenced and Corrupt Organizations (RICO) Act.

In a move derided by some health care stakeholders and applauded by others — including private payers — CMS on April 7 finalized its National Coverage Determination (NCD) for an Alzheimer’s treatment that has been steeped in controversy since it received accelerated approval last June.

The final coverage decision largely affirmed what CMS had proposed in its draft NCD: Medicare will cover Biogen Inc.’s Aduhelm (aducanumab) only for patients enrolled in randomized, controlled clinical trials conducted either through the FDA or the National Institutes of Health. Patients also must have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild dementia with a confirmed presence of plaque on the brain.

With its Feb. 28 approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel; cilta-cel) becomes the second chimeric antigen receptor T-cell (CAR-T) therapy to treat multiple myeloma. Payers report being less likely to prefer it over some or all other multiple myeloma treatments with a similar indication, but oncologists are showing more enthusiasm for prescribing the new agent, according to Zitter Insights.

The FDA approved Carvykti for the treatment of adults with relapsed or refractory multiple myeloma after at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. The product is a B-cell maturation antigen (BCMA)-directed CAR-T agent. The one-time treatment will have a phased launch and will be available through a limited network of certified treatment centers. The FDA gave the drug breakthrough therapy and orphan drug designations. The therapy’s wholesale acquisition cost is $465,000.

Optum, Inc. recently unveiled Optum Specialty Fusion, a specialty drug management solution that’s focused on streamlining care for people on those products and lowering medication costs. According to the company, which is part of UnitedHealth Group, the approach has the potential to deliver 17% total cost savings in health plans’ medical and pharmacy spend.

Providers are able to request prior authorization for specialty agents via a portal, which then compares treatment options, including their costs, across both the medical and the pharmacy benefit. According to the company, “informed by Optum data and insights, Specialty Fusion provides savings options such as preferred products, dosage management policies, best sites of care and additional cost-control levers such as available discounts and pharmacy networks.” The solution narrows down treatment options to the ones or one that “makes the most clinical and financial sense” and provides approval for that treatment in real time, regardless of the benefit the agent falls under. Optum maintains that this approach lessens “administrative hassle and results in an expected 50% faster access to therapy for patients, while lowering costs.” Specialty Fusion is available for large health plans.

When the COVID-19 pandemic struck, to say the health care system was disrupted is an understatement. Many people undergoing treatment for cancer rightfully were concerned about their potential exposure to the virus and were hesitant to leave their homes for care. In order to continue treating some patients, Horizon Blue Cross Blue Shield of New Jersey partnered with Rutgers Cancer Institute of New Jersey (CINJ) and RWJBarnabas Health to start a pilot to offer home infusion of cancer treatments and telemedicine support for eligible people, the first such program in the state.

In addition to not putting people at risk of acquiring an illness, home infusion means that people don’t have to travel for treatment. It also provides them with one-on-one care, close monitoring during infusions and the ability to schedule treatments around their personal schedule. These benefits are especially important for people with compromised immune systems.

The FDA has approved a handful of drugs to treat atopic dermatitis recently. Among them is LEO Pharma Inc.’s Adbry (tralokinumab-ldrm), an interleukin-13 (IL-13) antagonist. According to a Zitter Insights survey, payers may take a bit of a restrictive approach in managing the drug. And with multiple new biologics approved for the condition and more potential agents coming onto the market, payers may impose more utilization management strategies on the therapeutic class as a whole, say industry experts.

On Dec. 28, the FDA approved Adbry for the treatment of people at least 18 years old with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those treatments are not advisable. The decision made it the first biologic that LEO Pharma has launched in the U.S. Recommended dosing is an initial dose of 600 mg via four 150 mg subcutaneous injections and then 300 mg every other week.

Magellan Health’s PBM, Magellan Rx Management, recently unveiled a partnership with Zipline that will deliver prescription medications, including specialty drugs, to patients’ homes through the use of autonomous aircraft. The program will provide convenience to customers, maintains Mostafa Kamal, CEO of Magellan Rx Management, as well as reduce emissions compared with traditional delivery methods.