As many of you have become aware, KV Pharmaceuticals has received FDA approval to be the exclusive distributor for P17. They are planning to charge $1500 per injection for a total cost, per pregnancy, of $30,000!!!!
Pharmaceuticals has received FDA approval to be the exclusive distributor for P17. They are planning to charge $1500 per injection for a total cost, per pregnancy, of $30,000!!!!
The current cost is $10 per injection, or $200 per pregnancy.
There are several points that I would like to emphasize.
The rationale for a commercial maufacturer is to ensure a standard concentration. In theory, this can be a problem with compounding pharmacies although the vast majority of the compounding pharmacies producing this product tat present have extremly exacting standard. The March of Dimes has, unfortunately, bought into this rationale with absolutely no proof that a variation in strength is of any clinical significance. By law, once a drug is commercially available, compounding pharmacies must stop production of that drug.
We have been using P17 for the past ten years from these compounding pharmacies with obvious beneficial effect. So where is the rationale for this change?
March of Dimes receives several million dollars a year in support from KV Pharmaceuticals - I wonder why! This suggests to me that March of Dimes can be bought. I, personally, have informed the March of Dimes that I am ceasing all support of their organization, financial and otherwise, until they divorce themselves from KV Pharmaceuticals and support for Makena. They do not realize that they are going to cause an increase in the preterm birth rate, not a decrease. At best, there will be no change other that a massive over-expenditure of health-care dollars.
You have seen the propaganda stating that no-one will be denied the medication because of ability to pay. However, what they don't tell you is that they are going to use very strict criteria. In essence, the only women who will qualify is those who have had a prior preterm birth before 32 weeks secondary to preterm labor. To illustrate this more fully, Aetna/US Health care (one of the largest insurers in the country) covers this therapy when patients meet their strict criteria. Currently, they are paying for P17 for only 1,000 women nationwide per year! There are 4.2 million births in the US annually. 10 - 15%, or 420,000 to 610,000 are premature. And Aetna is only going to cover 1,000 of these women.
30% of all prenatal care is covered by Medicaid. An additional 10% is covered by charity care. KV is going to insist that since this care is not coming out of the patient's pocket, the cost should be borne by Medicaid and charity care. Currently, we can provide good prental care for about $2,000 per pregnancy. So for every patient placed on P17, we have to somehow find away to cover an additonal 15 pregnant patient. And who pays the medicaid and charity care bill? We all do through higher taxes and higher healthcare premiums!
Studies show that approximately 30 women need to be treated with P17 to prevent one preterm birth. At $200 per patient, this is very cost effective. That is an expendure of $6,0000 to save the average of $51,000 per preterm delivery. With current pricing, we will have to spend $9 million dollars in P17 therapy to save $51,000. Does this make sense? And people want to know why health care costs so much.
Most of you (greater than 90%) who will be on P17 now will be faced with doing without or paying $1500 per injection out-of-pocket. If you are currently on this medication, make sure that your doctors order enough for you right away to cover the enitre pregnancy. You could have as little as one week. If you are early in pregnancy or planning a pregnancy soon, talk to your doctors about getting this now to have on hand. Most suppliers warrant the drug to be effective for one year.
So, what can you do?
Firstly, contact KV Pharmaceutical and voice your displeasure:
KV Pharmaceuticals Contact Information: firstname.lastname@example.org
Second, notify your local media outlets about this issue.
Third, write or email your congressman and senator:
Fourth, contact the FDA and find out why they elected to give KV exclusivity for this product. Competition will bring down the price dramatically.
Fifth, write to the president:
Sixth, contact your state Medicaid offices and your insurance carriers. Get them involved
Seventh, get as many of your friends, family members, co-workers, etc. as possible to do the above.
Eighth, feel free to cut/paste/email the above to as many contacts as you can. Let's make this issue go viral!
If we can get enough of a protest mounted, we stand a chance of averting this "rape" of the healthcare system that is motivated almost entirely by a profit motive. Even if KV decides to not manufacture the drug for fear of losing money, we will be better off than with what they are currently planning.