Miguel Bronchud: Who Pays for New Drugs?

Miguel Bronchud, Co-Founder and Advisory Board at Regenerative Medicine Solutions, shared a post on LinkedIn:

“With the advent of oral Targeted Therapies (small molecular drugs that essential inhibit special activated oncogenes or block them into an inactive 3D conformation) we witnessed great progress in the treatment of many cancers. But who pays for these new drugs?

Probably the 1st one was Gleevec, also marketed internationally as Glivec and sometimes referred to by its chemical name imatinib, entered the medical world with a bang.

This medication was initially approved for use by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of chronic myelogenous leukemia (CML), a rare form of cancer that affects certain types of white blood cells. Since its initial approval, Gleevec has also been approved for use in patients with several types of gastrointestinal Stromal tumors GISTs).

When people say Gleevec is a miracle drug, or a “silver bullet”, they are usually referring to its phenomenal success rate. For instance, in one of the first clinical studies described in medical literature, oncologist Brian Druker and his colleagues reported that “complete hematologic responses were observed in 53 of 54 patients with chronic myeloid leukemia (CML), previously mainly incurable, treated with daily dosage of 300 mg or more and typically occurred in the first four weeks of therapy” (Druker et al., 2001).

Since then tens of different small molecules have been successfully approved for treatment of several types of cancers both in the potentially curative or palliative contexts. Most belong to the group of tyrosine kinase inhibitors (ending their generic names in -ib).

The group includes several oral inhibitors of Cyclin Kinases (key for some hormone receptors positive breast cancers) that are enzymes critical for the cell cycle- like entering the S-phase or DNA replication process allowing for cell division and cancer cells proliferation.

Despite their benefits, oral cancer treatments often come with higher out-of-pocket costs than traditional IV chemotherapy due to differences in insurance coverage. IV treatments are typically covered under a plan’s medical benefit, while oral drugs fall under the prescription benefit, creating cost disparities.

This is true not only in the USA, but also elsewhere like for example in the private sectors in Spain, where such oral therapies are often not covered by private healthcare insurance – patients require referral to public cancer hospitals to start/continue their correct anti cancer oral therapies (excluding some of the classical hormonal treatments already covered and available before).

43 states in the USA (alas some good news coming in the Trump second term era for cancer) and D.C. have passed “oral parity” laws requiring equal coverage for oral and IV treatments.

These laws have helped lower costs, but patients enrolled in federally regulated health plans remain unprotected?

The Cancer Drug Parity Act builds on the success of state-level reforms by ensuring equal coverage for all cancer patients, regardless of how their treatments are administered.

Specifically, the bill will:
– Expand oral parity protections to privately insured patients whose health care is regulated at the federal level.
– Prevent insurers from covering oral and self-administered medicines at different cost-sharing rates than IV chemotherapy.
– Implement these requirements for health plans that already cover both oral and IV chemotherapy treatments.

‘Oral chemotherapy should be covered just as widely as traditional IV treatments,’ said Rep. Bonamici. ‘Unfortunately, too many patients are forced to pay high costs and unaffordable co-payments because many oral cancer treatments are not covered by health insurance plans. I’m pleased to join my colleagues in leading the bipartisan Cancer Drug Parity Act’.

The bipartisan Cancer Drug Parity Act addresses the unequal coverage of oral therapies, empowering patients and healthcare providers to choose the most effective treatment path without financial barriers.

‘Cancer treatment should be guided by what works medically, not by outdated insurance policies.’

Targeted therapies are often very effective, but they only work for patients with specific genetic mutations or alterations in their tumors. For example, they have revolutionized treatment of many lung cancers of the non small cells types.

Some Oral Targeted Therapies:

• Osimertinib: A tyrosine kinase inhibitor (TKI) used for NSCLC with EGFR mutations. It is highly effective in reducing the risk of death from lung cancer in patients with this specific mutation.
• Erlotinib and Gefitinib: Other oral EGFR inhibitors used in NSCLC.
• Crizotinib, Ceritinib, Alectinib, Brigatinib: These are oral targeted therapies for ALK-positive NSCLC.
• KRAS inhibitors: These are oral targeted therapies for NSCLC with KRAS G12C mutations.
• Nintedanib: An oral targeted therapy used for adenocarcinoma NSCLC, often in combination with docetaxel.
• Entrectinib and Larotrectinib: Targeted therapies for NTRK fusion-positive lung cancers.”

Read the full article “New legislation set to improve drug access for American patients with cancer”.

More posts featuring Miguel Bronchud on OncoDaily.