Specialty Drugs

Most Payers Will Review Humira Biosimilars as They Come

Starting next year, biosimilars are expected to generate significant pharmacy cost savings for patients and payers, led by multiple biosimilars of AbbVie Inc.’s blockbuster immunosuppressive drug Humira (adalimumab). With as many as eight Humira competitors expected to launch in 2023, most payers report they will evaluate the biosimilars as they come to market over the course of the year, rather than waiting until all are available before making coverage decisions. And half of payers may adjust Humira contracting in 2022, prior to the biosimilars’ launches.

That’s according to findings from Zitter Insights, which like AIS Health is a division of MMIT. Steve Callahan, a senior manager of market research at MMIT, described Zitter’s market research findings on the Humira biosimilars during an April 5 webinar.

CMS Rule on Pharma Patient-Assistance Programs Could Cut Back on Aid

CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from best price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers — and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

Specialty Pharma Payer Deals Point to Outsourcing Trend

As prices for specialty pharmacy products continue to soar, payers are looking for new ways to gain more control over the distribution of expensive, often-provider-administered drugs. Last week, Kaiser Permanente and Highmark Blue Cross Blue Shield both struck deals aimed at managing specialty pharmacy spend — and one expert says that more deals like them are coming, especially from Kaiser’s new business partner, Cigna Corp. subsidiary Evernorth.

Kaiser Permanente (KP), the multistate integrated payer-provider based in California, doesn’t enter agreements with service providers outside its self-contained system very often. That said, Kaiser Permanente spokesperson Stephen Shivinsky tells AIS Health that “Kaiser Permanente and Accredo” — the specialty pharmacy division of Evernorth — “have had an existing relationship, which will expand further under part of this new agreement.”

A Look at Third-Party Oncology Clinical Pathways

In order to improve patient outcomes and reduce variations in oncology care, more and more payers and providers are adopting oncology clinical pathways (OCPs) — treatment protocols that aim to provide the optimal cancer care to patients at the lowest cost, according to a recent MMIT webinar. The share of oncologists exposed to third-party oncology pathways increased from 20% in 2015 to 52% in 2021, with one third of oncologists choosing a provider-focused pathway as of the fourth quarter of 2021. Breast cancer, multiple myeloma and non-small cell lung cancer are among the top therapeutic areas managed by third-party pathways.

Specialty Pharma Payer Deals Point to Outsourcing Trend

As prices for specialty pharmacy products continue to soar, payers are looking for new ways to gain more control over the distribution of expensive, often-provider-administered drugs. Last week, Kaiser Permanente and Highmark Blue Cross Blue Shield both struck deals aimed at managing specialty pharmacy spend — and one expert says that more deals like them are coming, especially from Kaiser’s new business partner, Cigna Corp. subsidiary Evernorth.

Kaiser Permanante (KP), the multistate integrated payer-provider based in California, doesn’t enter agreements with service providers outside its self-contained system very often. That said, Kaiser Permanente spokesperson Stephen Shivinsky tells AIS Health that “Kaiser Permanente and Accredo” — the specialty pharmacy division of Evernorth — “have had an existing relationship, which will expand further under part of this new agreement.”

A Look at Third-Party Oncology Clinical Pathways

In order to improve patient outcomes and reduce variations in oncology care, more and more payers and providers are adopting oncology clinical pathways (OCPs) — treatment protocols that aim to provide the optimal cancer care to patients at the lowest cost, according to a recent MMIT webinar. The share of oncologists exposed to third-party oncology pathways increased from 20% in 2015 to 52% in 2021, with one third of oncologists choosing a provider-focused pathway as of the fourth quarter of 2021. Breast cancer, multiple myeloma and non-small cell lung cancer are among the top therapeutic areas managed by third-party pathways.

Novartis’ Pluvicto Brings New Option to mCRPC Treatment

A new prostate cancer drug is sparking interest among payers and oncologists alike, according to a survey by Zitter Insights.

On March 23, the FDA approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The product from Novartis unit Advanced Accelerator Applications USA, Inc. is the first FDA-approved targeted radioligand therapy for eligible people with mCRPC that combines a targeting compound with a therapeutic radioisotope.

CMS Targets Patient-Assistance Programs; Rule Could Curtail Aid

CMS’s stance has long been that manufacturer-provided assistance given to patients is excluded from Best Price and average manufacturer price (AMP) calculation for prescription drugs. However, the rise of copayment accumulators and maximizers and health insurers’ subsequent taking of this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums have caused the agency to rethink its position. A rule slated to take effect at the beginning of 2023 would reverse that longtime approach, potentially resulting in increased patient out-of-pocket costs for drugs and pharma companies being on the hook for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ Best Price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

Carvykti Approval Brings Second CAR-T to Multiple Myeloma Treatment

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.

Similar Adherence Is Seen in Digital, Telephonic Offerings

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.