The year 2022 has been promising in terms of progress in the oncology space. More FDA approvals have come in, providing more treatment options for various types of cancer. Last year’s growth will certainly help drive further improvement in treatment in 2023. Here we discuss some events from the past 12 months that will also impact our cancer patients moving forward.
1: Inflation Reduction Act of 2022.
This law will provide the most sweeping insurance reform since the Affordable Care Act and could actually help even more patients. The cost of oral oncolytics is now a staggering $20,000 to $30,000 a month, and insurance plans with 20% co-pays were never designed for that. Lifetime limits on insurance payments are now hitting our survivors hard and they will be lifted so patients keep coverage as they live longer.
Several additional provisions will certainly help our patients financially. Starting in 2023, insulin and durable supplies will be capped at $35 a month for Medicare patients. In 2024, the “catastrophic phase” of drug costs will no longer require patient copayments, and in 2025, the cap on all drug payments will be $2,500. Medicare’s “expansion” and affordable drug plans will continue to be offered through the market, and benefits will continue through the end of 2025, saving about $800 annually for every patient enrolled in these Medicare plans.
2: Drug price controls.
As a result of the Inflation Reduction Act, Medicare will be able to negotiate drug prices for the first time ever, starting in 2024. Instead of paying the price for one new drug, CMS will announce 10 drugs (selected from the most expensive brand drugs without competitors) for negotiation, with prices negotiated starting in 2026. Fifteen more medicines will be negotiated in 2027 and, starting in 2028, 20 medicines will be negotiated each year. For the first time, Americans will benefit from the same process used by many government health authorities around the world, so that we no longer bear more than our fair share of the costs of new drugs.
3: New drug approvals.
The FDA approved 7 new oncology drugs this year, the most recent of which is a new antifolate receptor antibody-drug conjugate (ADC) for ovarian cancer, mirvetuximab soravtansine-gynx (Elahere). The others approved were tebentafusp-tebn (Kimmtrak), a gp100xCD3 bispecific antibody for uveal melanoma; relatlimab-rmbw (Opdualag), a fixed-dose combination of relatlimab, an LAG-3 blocking antibody, plus nivolumab (Opdivo) for melanoma; futibatinib (Lytgobi), an FGFR inhibitor for cholangiocarcinoma; tremelimumab (Imjudo) plus durvalumab (Imfinzi) for unresectable hepatocellular carcinoma; teclistamab-cqyv (Tecvayli), a bispecific antibody to CD3 B-cell maturation antigen (BCMA) for use in fifth-line or subsequently relapsed/refractory multiple myeloma; and a second peptide radionuclide receptor therapy (PRRT) agent, lutetium Lu 177 vipivotide tetraxetan (Pluvicto), for prostate cancer.
There have been continued advances in the use of immune checkpoint inhibitors (ICIs), with new agents targeting LAG-3 and new indications for combined anti-CTLA-4 and anti-PD-1. Furthermore, the benefits of previous use of anti-PD-1 for high microsatellite unstable tumors were first demonstrated in cases of colon and rectal cancer, perhaps eventually to supplant chemotherapy, radiotherapy and surgery.
5: Cell Therapy.
Chimeric antigen receptor (CAR) T-cell therapies have continued to expand their utility, with approvals for their use in sustained and refractory relapses follicular lymphoma. Lisocabtagene maraleucel (Breyanzi) has been approved for second-line therapy in large cell lymphoma and idecabtagene vicleucel (Abecma), directed against BCMA, has been approved for refractory myeloma.
6: CRISPR has entered the clinic.
This new technology incorporates DNA guides based on bacterial ‘clustered regularly interspersed palindromic repeats’ and can now be used for real genetic engineering in human patients. With the FDA approval of betibeglogene autotemcel (Zynteglo) in August under the 21st Century Cures Act (specifically, the provisions for advanced regenerative medicine therapy), patients with transfusion-dependent double mutation β-thalassemia, who cannot be treated with stem cell transplantation, can have their own stem cells CRISPR-edited to reinsert copies of their normal β-hemoglobin genes. This one-time treatment will cost an estimated $1.8 million, but is believed to be cost-effective given the costs of frequent transfusions and iron overload syndrome treatments.
7: Biosimilar Approvals.
With 4 more biosimilars approved in 2022 – pegfilgrastim, bevacizumab, an additional filgrastim and ranibizumab, a VEGF product for eye injection – the number of approved biosimilars has now reached 34. These continue to be identified by 4-letter suffixes to create “biosimilar brand .” These are not interchangeable or substitutable, wreaking havoc in our pharmacies and approval processes.We are again asking the FDA to make them more like “generics” when prescribing, as there is currently no clinical basis for preferring a biosimilar over a another.
Looking to 2023, what can we expect? To get started, read more immuno-oncology studies and further define the use of current and new ICIs. We will also see new ADCs, new PRRT agents, and continued advances in cell therapies including CAR T, T-cell receptor-based therapy, and tumor infiltrating lymphocytes. We can expect more genetic engineering using CRISPR now that the barrier has been broken, costing up to $3 million per treatment. It promises to be an exciting year. Happy New Year to all.