paywalled- Gynecologic Oncology - Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer ($8,699,872 monthly.

ScienceDirect.com - Gynecologic Oncology - Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer

Objective

To determine the potential economic impact of a paclitaxel drug shortage in patients with newly diagnosed, untreated ovarian cancer.

Methods

A modified Markov state transition model with a 6 cycle time horizon compared two scenarios: (1) Standard treatment (STD): paclitaxel 175 mg/m2/carboplatin AUC 5 × 6 cycles; (2) Paclitaxel drug shortage (DS): docetaxel 75 mg/m2/carboplatin AUC 5 × 6 cycles. Adverse events, quality of life, and costs of chemotherapy, neuropathy, febrile neutropenia, and anemia were incorporated. Key assumptions: (1) Costs and consequences were assigned only to grade 2 + neuropathy, febrile neutropenia, and grade 3–4 anemia; (2) Grade 2 + neuropathy prompted a switch from paclitaxel/carboplatin to docetaxel/carboplatin or from docetaxel/carboplatin to carboplatin alone; (3) Febrile neutropenia resulted in inpatient hospitalization followed by G-CSF prophylaxis.

Results

The mean cost of 6 cycles of chemotherapy was $4939 in the STD and $16,107 in the DS scenario, for a cost difference of $11,168 per patient over 6 cycles of treatment. STD was the dominant strategy (less expensive and more effective than the drug shortage scenario). In sensitivity analysis, DS was more costly over a wide range of clinical estimates in each arm. A drug shortage that affects approximately 50% of women initiating chemotherapy is expected to impact 779 women and cost third party payers an additional $8,699,872 monthly.

Conclusions

Our model indicates that chemotherapy drug shortages can have a significant negative impact on the average cost of primary treatment for ovarian cancer and have the potential to negatively impact health system costs.

Current Drug Shortages: Paclitaxel Injection (updated)

Current Drug Shortages: Paclitaxel Injection (updated):

APP is currently back-ordered on 100 mg/16.7 mL vial (NDC 63323-0763-16) and 300 mg/50 mL vial (NDC 63323-0763-50). 30 mg/5 mL vial (NDC 63323-0763-05) is currently available.

Current Drug Shortages: Ondansetron Injection 2 mg/mL (updated)

Current Drug Shortages: Ondansetron Injection 2 mg/mL (updated):

APP has Ondansetron 2 mg/mL 2 mL vials on back order with an estimated release date of early May 2012. Check wholesalers for inventory. The 40 mg, 20mL vials are on back-order until late May.

Current Drug Shortages: Paclitaxel Injection (updated)

Current Drug Shortages: Paclitaxel Injection (updated):

Teva has all presentations available with ample inventory.

Current Drug Shortages: Etoposide solution for injection (updated)

Current Drug Shortages: Etoposide solution for injection (updated):

Bedford Laboratories has 100mg/5ml available in limited quantities. Once this supply is depleted, the next estimated release dates are unknown. All other presentations are out os stock and the company cannot estimate a release date. Production is pending as capacity permits. Availability of products is updated on the Bedford Laboratories website. Etoposide Injection 20 mg/mL; 5 mL; 53776 vials in stock; approximately 45000 vials will be in warehouse by the 3rd week of this month.

The Drug Shortage Wars | The Health Care Blog (ovarian cancer untreated for weeks)

The Drug Shortage Wars | The Health Care Blog

The Drug Shortage Wars

2 Responses

By Sanjay Bansu, MD

“I should have gotten cancer last month,” she told me.

That was the first thought from my patient after she’d heard the news: her ovarian cancer would remain untreated for weeks, due to a critical shortage of the chemotherapy agent doxorubicin. Like her, several thousand patients have been affected by critical shortages of chemotherapy agents like doxorubicin (Doxil) and methotrexate—common medicines that are essential backbones of cancer chemotherapy. But hundreds of other people have also been affected by critical shortages of pills around the country—limiting the supply of critical ICU medications like intravenous versed, or tuberculosis drugs like isoniazid.

Why are these shortages happening, and what can be done about them?....

 Related Posts

abstract: Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer (astounding figures)

Economic impact of paclitaxel shortage in patients with newly diagnosed ovarian cancer - NCBI

Abstract

OBJECTIVE:

To determine the potential economic impact of a paclitaxel drug shortage in patients with newly diagnosed, untreated ovarian cancer.

RESULTS:

...... A drug shortage that affects approximately 50% of women initiating chemotherapy is expected to impact 779 women and cost third party payers an additional $8,699,872 monthly.

CONCLUSIONS:

Our model indicates that chemotherapy drug shortages can have a significant negative impact on the average cost of primary treatment for ovarian cancer and have the potential to negatively impact health system costs.

Current Drug Shortages: Paclitaxel (Taxol) Injection (updated)

Current Drug Shortages: Paclitaxel Injection (updated):

Hospira product 30 mg/5 mL vial (NDC 0409-0342-09): ample levels of inventory to support market demand. Product 300 mg/50 mL vial (NDC 0409-0342-50): ample levels of inventory to support market demand. Product 100 mg/16.7 mL vial (NDC 0409-0342-22): next delivery April. Please check with your wholesaler for available inventory. Teva has 30 mg/ 5 ml vial on backorder until April 2012. All other presentations are available with ample inventory.

FDA commissioner talks counterfeit drugs (and drug shortages) - CNN.com

FDA commissioner talks counterfeit drugs - CNN.com

US drug shortages could continue for years : The Lancet

US drug shortages could continue for years : The Lancet

Drug Shortages > Current Drug Shortages - Ondansetron Injection 2 mg/mL

Drug Shortages > Current Drug Shortages

FDA U.S. Drug Shortages - Paclitaxel (Taxol)

Paclitaxel Injection (updated 3/2/2012)

Company/Products	Reason	Related Information
Sandoz: 1-800-525-8747 6 mg/mL injection 30 mg/5 mL vial (NDC 66578-0043-01) 100 mg/16.7 mL vial (NDC 66578-0043-02) 300 mg/50 mL vial (NDC 66578-0043-03)	Manufacturing delays	Sandoz is currently on backorder.
APP 1-888-386-1300 6 mg/mL injection 30 mg/5 mL vial (NDC 63323-0763-05) 100 mg/16.7 mL vial (NDC 63323-0763-16) 300 mg/50 mL vial (NDC 63323-0763-50)	Increase in demand	APP is on intermittent back order and is releasing product as it becomes available.
Hospira Inc. Customer Service: 1-877-946-7747 300 mg/50 mL vial (NDC 0409-0342-50) 30 mg/5 mL vial (NDC 0409-0342-09) 100 mg/16.7 mL vial (NDC 0409-0342-22)	Higher than anticipated market demand.	Product 30 mg/5 mL vial (NDC 0409-0342-09): ample levels of inventory to support market demand. Product 300 mg/50 mL vial (NDC 0409-0342-50): next delivery March. Product 100 mg/16.7 mL vial (NDC 0409-0342-22): next delivery April. Please check with your wholesaler for available inventory.
Bedford Laboratories 1-800-562-4797 6 mg/mL injection 30 mg/5 mL vial (NDC 55390-0114-05) 100 mg/16.7 mL vial (NDC 55390-0114-20) 300 mg/50 mL vial (NDC 55390-0114-50)	Manufacturing delays	Bedford has all paclitaxel presentations on backorder and the company cannot estimate a release date.
Teva 1-800-545-8800 6 mg/mL injection 30 mg/5 mL vial (NDC 00703-4764-01) 100 mg/16.7 mL vial (NDC 00703-4766-01) 150 mg/25 mL vial (NDC 00703-4767-01) 300 mg/50 mL vial (NDC 00703-4768-01)	Manufacturing delays	Teva continues to release Paclitaxel 30mg/5mL vial (NDC 00703-4764-01), Paclitaxel 100mg/16.7mL vial (NDC 00703-4766-01), Paclitaxel 150mg/25mL (NDC 00703-4767-01) and Paclitaxel 300mg/50mL (NDC 00703-4768-01) as it becomes available
Sagent Pharmaceticals 1-866-625-1618 30mg/5mL NDC 25021-213-05 100mg/16.7mL NDC 25021-213-17 300mg/50mL NDC 25021-213-50		Sagent has the 5mL and 16.7mL on allocation and the 50mL product is available.

Drug Shortages > Daunorubicin Hydrochloride Solution for Injection (updated 2/24/2012)

"The company cannot estimate a future release date for more product."

U.S. FDA - Drug Shortages (sign up for drug shortage email noticiations)

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Drug Shortages

FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. The agency works closely with manufacturers of drugs in short supply to communicate the issue and to help restore availability. FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage.
Manufacturers are not required to report information, such as reasons for shortages or the expected duration of shortages. However, many companies voluntarily provide shortage information that FDA posts on its website. FDA encourages and appreciates all reporting of shortages by manufacturers. Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov.

Drug Shortages > Current Drug Shortages U.S. FDA listed as at 1/23/2012

The Drug Shortage Crisis in America - Forbes

Glenn D. Braunstein, M.D.: What's Behind Our National Drug Shortages?

Glenn D. Braunstein, M.D.

Chairman of the Department of Medicine, Cedars-Sinai

Johnson & Johnson Profit Slumps 89% on Charges - WSJ.com (references to Doxil/drug shortages)

"Mr. Weldon said J&J learned a "painful lesson" from the ongoing supply shortage for its drug Doxil, which treats ovarian and other cancers, and will try to have better contingency plans to avoid such disruptions in the future.
J&'s sole supplier for Doxil, Ben Venue Laboratories, late last year suspended production at its Ohio plant to focus on fixing manufacturing deficiencies cited by government regulators, including contamination. Ben Venue, a unit of Boehringer Ingelheim GmbH, doesn't expect to have new Doxil supplies until late 2012............"

Patients left in lurch by cancer drug shortage - ABC Online

Patients left in lurch by cancer drug shortage ABC Online Hospitals are running short of an important drug used to treat several forms of cancer after its American manufacturer decided to temporarily halt production. Doxil, known as Caelyx in Australia, is used to treat breast, ovarian and a rare form of skin ... and more »

U.S. news writer requests interviews: re: drug shortages cancer patients

From: <acarrns@aol.com>
Date: Wed, May 25, 2011 at 3:05 PM

I'm a freelance writer.. This year's topic is the impact of ongoing drug shortages, and I'm seeking to interview a patient or two (or their family) who has been affected by this. Some cancer patients, for example, are having trouble getting a drug called cytarbarine, and there are a host of others in shortage too. Would you have any suggestions for reaching such patients? of course am trying to do this as soon as possible, in next week or so.
thanks


Ann Carrns for U.S. News
404-229-3523