Overview of the oncological year

The year 2022 was promising in terms of progress in the oncology space. They have received multiple FDA approvals, providing additional treatment options for various types of cancer. Last year’s growth is sure to help drive further treatment improvements in 2023. Here we discuss some of the events of the past 12 months that will also impact our cancer patients, moving forward.

1: The Inflation Reduction Act of 2022

This bill will provide the most comprehensive 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 per month, and insurance plans with 20% co-pays were never designed for that. Lifetime limits on insurance payouts are now viciously affecting our survivors and will be eliminated so that patients will retain coverage while they live longer.

A few additional provisions will definitely help our patients financially. Starting in 2023, insulin and permanent supplies will be capped at $35 per month for Medicare patients. In 2024, the “catastrophic phase” of drug costs will no longer require patient co-payments, and in 2025, the full payment limit for all drugs will be $2,500. Medicare “expansion” and affordable drug plans will continue to be offered through the marketplace and subsidies will continue through the end of 2025, saving approximately $800 per year for each patient enrolled in these Medicare plans.

2: Drug price control.

As a result of the Inflation Reduction Act, Medicare will be able to negotiate drug prices for the first time in history, starting in 2024. Instead of paying the price for a new drug, CMS will post 10 drugs (selected from among the most expensive brand name drugs with no competitors) up for negotiation, with agreed prices from 2026. In 2027, another 15 medicines will be negotiated, and from 2028, 20 medicines will be negotiated annually. For the first time, Americans will benefit from the same process used by many government health authorities around the world, so that we will no longer bear more than our fair share of the costs of new drugs.

3: Approvals of new drugs.

The FDA has approved 7 new oncology drugs this year, most recently a new antifolate receptor antibody-drug (ADC) conjugate for ovarian cancer, mirvetuximab soravtansine-gynx (Elahere). Others approved were tebentafusp-tebn (Kimmtrak), a bispecific gp100xCD3 antibody for uveal melanoma; relatlimab-rmbw (Opdualag), a fixed-dose combination of relatlimab, a 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 B cell maturation antigen (BCMA) CD3 antibody for use in fifth-line or later relapsed/refractory multiple myeloma; and another peptide radionuclide receptor therapy (PRRT) agent, lutetium Lu 177 vipivotide tetraxetane (Pluvicto), for prostate cancer.

4: Immunotherapy.

There has been continued progress in the use of immune checkpoint inhibitors (ICIs), with new agents directed against LAG-3 and new indications for combined anti-CTLA-4 and anti-PD-1. In addition, the benefits of earlier use of anti-PD-1 for tumors with high microsatellite instability were demonstrated for the first time in colon and rectal cancer, perhaps ultimately replacing chemotherapy, radiation therapy, and surgery.

5: Cell therapy.

Chimeric antigen receptor (CAR) T-cell therapies have continued to expand their utility, with approvals for use in prolonged relapse and refractory follicular lymphoma. Lisocabtagene maraleucel (Breyanzi) is approved for second-line therapy in large cell lymphoma, and idecabtagene vicleucel (Abecma), directed against BCMA, is approved for refractory myeloma.

6: CRISPR has entered the clinic.

This new technology involves DNA guides based on bacterial “clustered regularly interspersed palindromic repeats”, and can now be used for actual genetic engineering in human patients. With the FDA approval of betibeglogene autotemcel (Zynteglo) in August, under the 21st Century Cures Act (specifically, the Advanced Regenerative Medicine Provisions), patients with transfusion-dependent double-mutated β-thalassemia, who cannot be treated with stem cell transplantation, they can undergo CRISPR editing of their own stem cells to reinsert copies of normal β-hemoglobin genes. This one-time treatment will cost an estimated $1.8 million, but is thought to be cost-effective, given the cost of frequent transfusions and treatment for iron overload syndrome.

7: Approvals for biosimilars.

With 4 more biosimilars approved in 2022 — pegfilgrastim, bevacizumab, additional filgrastim and ranibizumab, a VEGF product for ocular injections — the number of approved biosimilars has now reached 34. They continue to be identified by 4-letter suffixes to create “branded biosimilars.” They are not interchangeable or interchangeable, causing chaos in our pharmacy and approval processes. We again urge the FDA to make them more similar to “generics” in prescribing, as there is no clinical basis for favoring one biosimilar over another at this time.

Looking ahead to 2023, what can we expect? For starters, multiple immuno-oncology trials that read continue to 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. Now that the barrier has been broken, we can expect further genetic engineering using CRISPR, with costs of up to $3 million per treatment. It promises to be an exciting year ahead. Happy New Year to everybody.

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