You may have seen or heard the news about KV Pharmaceuticals’ introduction of Makena, a form of progesterone that can help reduce the risk of premature labor.
The drug itself isn’t new. Doctors have used compounding pharmacists to prepare hydroxyprogesterone injections for decades at an average cost of between $10 to $50 a dose. What is new is that KV Pharmaceuticals used a formula in the public domain, submitted it to the FDA for review, received approval to market the product and… set the price at $1,500 per dose!
As a result, we have received many calls from understandably upset consumers who are worried whether or not they or their family members can still use their local compounding pharmacist for this drug. To help you and your family understand what’s going on, we’ve prepared a list of the most frequently asked questions.
What is all the buzz about Makena?
KV Pharmaceuticals submitted an orphan drug application for Makena (hydroxyprogesterone caproate for injection, also known as 17P) to the FDA last year. Orphan drugs are products used to treat rare disease or for which there are a very few patients. The Food & Drug Administration approved their application on 4 February 2011. As an orphan drug, Makena receives exclusive marketing privileges for a set period of years. In other words, no other manufacturer or generic company can make the product until that amount of time has passed.
How can they get approval for something that’s been around for so long?
Hydroxyprogesterone caproate for injection used to be sold as Delalutin, a product that went off-patent more than 30 years ago. Even though the drug was no longer manufactured, compounding pharmacists could still acquire the raw ingredients and prepare prescriptions for patients. KV Pharmaceuticals used the publicly available formula, invested in clinical studies, and submitted their application to the FDA as a “new” drug. That’s completely legal and is something many entrepreneurial pharmaceutical companies have done lately – make old drugs “new” again.
Why does it cost so much?
According to KV Pharmaceuticals investor relations briefing documents, Makena will be sold in 5 dose vials at approximately $7,500/vial ($1,500 per dose). The company has also reported that the product has a gross profit margin of 97.5%. Pharmaceutical manufacturers are responsible for setting the price of drugs sold. The FDA does not establish a price for drugs in the US. The price decision was entirely up to KV Pharmaceuticals.
Can pharmacists still compound the drug?
As with all compounds, the decision to develop a compounded preparation should be based on the recommendation of your prescriber and pharmacist team who will address your specific clinical and therapeutic needs. If in the professional judgment of both your prescriber and the pharmacist it is appropriate to compound a hydroxyprogesterone caproate product rather than using the now manufactured product, then you should be able to obtain the compound. Always discuss your medication needs with your doctor and your pharmacist.
Is Makena covered by insurance?
Some third-party payers have already announced they will include Makena as part of their prescription benefit programs. What tier and copayment will be required is dependent upon each individual program and their formulary decision process. Because many patients who suffer from pre-term labor are poor or uninsured, state Medicaid programs will need to determine coverage as well. Each state program, just like each prescription insurance plan, is looking at the cost of Makena and making that decision. Before receiving Makena, your pharmacist can verify and discuss coverage with both you and your prescriber. KV Pharmaceuticals has also announced they are establishing a patient assistance program to help those consumers who can’t afford Makena.
I’ve read in the news that KV Pharmaceuticals sent letters to compounders saying they can’t compound hydroxyprogesterone any more.
Some compounders did receive a letter from KV Pharmaceuticals dated 17 February 2011 which essentially said pharmacists shouldn’t compound a product that’s FDA approved. In our estimation, the letter is nothing more than a “scare tactic” and part of KV Pharmaceutical’s pre-launch marketing campaign. Please be aware that no legal action has been taken against compounders by the company; the product isn’t even on the market until this week. Pharmacists can legally compound FDA approved products when a prescriber determines that the compounded preparation is more clinically appropriate for an individual patient.