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Pricing of the treatment for Non-Muscle Invasive Bladder Caner (NMIBC)
The price of cancer treatment tends to be very expensive for general public. Keytruda is PD-1 immune checkpoint inhibitor which is used as immunotherapy. It has been used to treat advanced bladder cancer and for NMIBC, it had been approved to treat BCG Unresponsive patients. The list price of Keytruda for one treatment is $10,474.08 when given every 3 weeks according to MERCK Keytruda site. That means the annual cost will be about $180K for a patient. Though MERCK provides complicated discount schemes to reduce the price, how can MERCK justify charging such high price? Why not $10K per year instead of $180K? Or, why not $500K? In principle, in the US, the price of the drug is not regulated. There was a study done in this matter for 10 cancer drugs approved by FDA. The median cost of developing a single cancer drug was $650 million. The median revenue after approval for such a drug was $1,658 million. The clinical trial for all cancer drugs between 2015-2017 was $32 million – median cost, with some large clinical trial costs over $100 million. Only 4% of cancer drug related clinical trials succeed. So, it kind of makes sense that cancer drugs are priced high.
Actually, there happens to be an organization which determines what is the justifiable price based upon various factors. The Boston based independent non profit organization is called The Institute for Clinical and Economic Review (ICER). ICER uses a formula based on quality-adjusted life years (QALYs), which generates an estimated dollar benefit for a drug, and then compares this number to the drug’s actual list price.
There are two FDA approved drugs for BCG Unresponsive NMIBC. One is VALSTAR® (valrubicin) which was approved in 1981. The other one is Keytruda (R) (pembrolizumab). There are two new drugs pending upon the approval of FDA. One is nadofaragene firadenovec by Fergene and the other drug is Vicinium ( oportuzumab monatox) by Sesen Bio. Sesen bio Vicinium was rejected at the end of Phase III and needs to require additional tests to meet FDA requirement.
ICER analyzed both drugs and came to its pricing as follows.
nadofaragene firadenovec 158,600-$262,000 per year Intravesical
Vicinium (R) ( oportuzumab monatox) $93,000-$162,000 per year IntravesicalThe performance data which ICER used is as follows.
Nadofaragene Firadenovec: Complete Response and High-Grade Recurrence Free Survival, CIS ± Ta/T1 and Ta/
3 months 53.4%
6 months 40.8%
9 months 35%
12 months 24.3%Oportuzumab Monato Vicinium(R) Sesen Vicinium
Complete Response/High Grade RFS (%) for CIS +/Ta/T1
3 months 40%
6 months 28%
9 months 21%
12 months 17%
Pembrolizumab Keytruda (R) Merck Complete Response (%) for CIS +/Ta/T1
3 months 40.5%
6 months 38%
9 months 28%
12 months 19%
15 month 19% -
3 Replies
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Annual cost was truncated, so I edited the document.
Note that the list includes only drug cost and does not include what hospital charges such as administration of the drug, i.e. intravenous in case of Keytruda and intravesical for other drugs. In case of Gemcitabine +Docetaxel, ICER report showed only the cost for 6 weeks induction treatment, so I have added monthly 10 months treatment which is the protocol of one hospital. Those new treatment for BCG Unresponsive definitely requires more than Medicare Plan B to have less financial impact such as Medicare supplement (Medigap). But a web site says the open enrollment window is six months, beginning the date your Medicare B becomes effective. When we look at published data, even with those new treatments, the disease free (no recurrence no progression) survival rate (DFS) is about 20% at 12 months, indicating many patients ending up with muscle invasive bladder cancer will may require radical cystectomy, and adjuvant immunotherapy (Nivolumab) or maintenance immunotherapy (Avelumab) or Keyturda as the first line treatment when chemotherapy did not work for advanced bladder cancer. These treatment also cost $150K list price a year. I understand that more than 40% of all original Medicare beneficiaries purchase Medigap, so that is good. But if not, it may be advisable for patients who are receiving BCG treatment to talk with Medicare specialists or talk with you hospital so you are under insured. I have impression from what I read on the internet that many doctors (urologist/oncologist) do not know about the cost impact of the treatment they recommend to their patients. So, it sounds like patients must take proactive role to be aware of these matters.Drug cost Annual drug cost
per treatment
Keytruda by MERCK 200 mg every 3 weeks $9,455 $164,337Vicineum by Sesen Bio 30mg twice weekly for 6 weeks, $4,167 $150,000
then once weekly for 6 weeks,
then every two weeks there after
(total of 36 doses in first year)
Nedofragene Firadenovec 75 ml every 3 months $41,084 $164,337
by FerGene
Gemcitabine 1000mg 6 weeks induction $72.76 $1,164.6
+ Decetaxek 37.5mgIf it is only Medicare plan B, 20% co pay will be billed right after the treatment, Co-pay payment schedule
Co-pay Annual Co-pay
Keytruda by MERCK Every 3 weeks $1,891 $32,867Vicineum by Sesen Bio 36 times a year $831 $30,000
Nedofragene Firadenovec Every 3 months $8.217 $32,867
by FerGeneGemcitabine 1000mg 6 weeks induction plus $15 $233
+ Docetaxel 37.5mg monthly for 10 months -
Yes, it is going to be tricky for patients with BCG treatment in term of out of pocket expenses. We used to have BCG + Interferon alpha-2b for BCG Unresponsive, but MERCK dropped that business so that option is gone. BCG+Interferon was inexpensive. Great to have new treatments but they are expensive. Patients need to be savvy about their insurance coverage. Medicare Plan B covers these new treatments as these treatments are done in the hospital. But, Medicare Plan B covers only 80% and 20% must be paid by the patient unless the patient has other coverages. So plan B, if the annual fee for the treatment is $100K a year, the patient must pay $20K our of his or her pocket per year. Then there is Medicare advantage, Medicap, etc to supplement the payment, making things more complicated. Maybe someone here in the forum can post how they are managing finance including the insurance plan to cover the cost of treatments. Bladder cancers are seniors’ cancer. Patients are mostly retired and many are living on pensions and eating up savings.
Drug cost per treatment Annual Drug cost
Keytruda by MERCK 200 mg every 3 weeks $9,455 $164,337Vicineum by Sesen Bio 30mg twice weekly for 6 weeks, $4,167 $150,000
then once weekly for 6 weeks,
then every two weeks there after
(total of 36 doses in first year)
Nedofragene Firadenovec 75 ml every 3 months $41,084 $164,337
by FerGeneIf it is only Medicare plan B, 20% co pay will be billed right after the treatment, Co-pay payment schedule will look like below.
Co-pay Annual Co-pay
Keytruda by MERCK Every 3 weeks $1,891 $32,867Vicineum by Sesen Bio 36 times a year $831 $30,000
Nedofragene Firadenovec Every 3 months $8.217 $32,867
by FerGeneWe know Gemicitabine + Docetaxel has been adopted for the treatment for NCG Unresponsive. ICER reports it as follows
Cost per treatment Initial 6 weeks + once a month for 10 months
Gemcitabine 1000mg $36.90
+ Decetaxek 37.5mg $35.86 $437 + $727.6Dr. Ashishi Kamat of MD Andersons said he would recommend his patients Gem+Doc over Keytruda for BCG Unresponsive in his practice because GEM+DOC is better in efficacy and side effects. BCG costs $120-$150 per dose, so it seems we have Gem+Doc as equally inexpensive treatment for BCG unresponsive. Still patients who are being treated with BCG for high risk NMIBC may want to explore what Medicare plans are suited for these new treatments.
best
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Very interesting, and very scary, Joe!! Thank you for the research and for posting this!
Sara Anne
Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
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