Deb, with most Part D plans, if a beneficiary asks for an exception and it is granted, they cover it at a preferred brand copay, which is typically around $45 or so. Thus they're no better off going this route -- might as well procure it from the store at market price.
Part D, Armour Thyroid
- Thread starter GoPokes
- Start date
Deb, with most Part D plans, if a beneficiary asks for an exception and it is granted, they cover it at a preferred brand copay, which is typically around $45 or so. Thus they're no better off going this route -- might as well procure it from the store at market price.
I know that this is an old post but there is some bad misinformation being given here. I work in the pharmacy industry and have worked for several PBMs with Part D contract. Armour Thyroid / Nature-Throid (dessicated thyroid) are not FDA approved. They are what is considered to be a DESI drug meaning that it was originally FDA approved between 1938 and 1962 and was only study for safety. After 1962 the FDA required that drugs are studied for safety and efficacy prior to being approved and the natural thyroid products (Armour Thyroid and Nature-Throid) have not undergone those studies and thus have never received full FDA approval. CMS law does not allow Part D plan sponsors to cover Armour Thyroid and other dessicated (natural) thyroid products. Read below for more information.
From CMS Chapter 6 that dictates what constitutes a "covered drug"
"10.9 - DESI Drugs
(Rev. 2, Issued: 07-18-08; Effective/Implementation Date: 07-18-08)
For a drug to be available for reimbursement by a Part D sponsor it must meet the definition of a Part D drug. Section 1860D–2(e)(1) of the Social Security Act (the Act) generally defines a Part D drug to include those drugs that may be dispensed only upon a prescription and that meet the
requirements of section 1927(k)(2) of the Act. Section 1927(k)(2) generally requires that the drug be approved by the FDA or otherwise described under sections 1927(k)(2)(A)(ii) or (A)(iii) of the Act. These provisions address those drugs affected by the Drug Amendments of 1962 (amending the Federal Food, Drug & Cosmetic Act), which require that a new drug be proven effective, as well as safe. FDA"s Drug Efficacy Study Implementation (DESI) evaluates the effectiveness of those drugs that had been previously approved on safety grounds alone. FDA indicates that these drugs, and those identical, related, and similar to them, may continue to be marketed until the administrative proceedings evaluating their effectiveness have been concluded, at which point continued marketing is permitted only if a new drug application (NDA) or abbreviated new drug application (ANDA) is approved. The vast majority of the DESI proceedings have been concluded, but a few are still pending.
The definition of a Part D drug does not include less than effective (LTE) DESI drugs or those identical, related or similar drugs to the LTE DESI drug. As FDA continues to undertake reviews under the DESI program and announces results of its hearings, CMS would expect Part D sponsors to adjust their formularies accordingly, as they should with any other applicable FDA
drug product announcement. If a sponsor discovers the presence of any LTE DESIs on its formulary based on an FDA announcement or otherwise, it should remove these drugs from the formularies on accordance with section 30.3."
From the FDA website:
Proprietary Name: Armour Thyroid
Non-Proprietary Name: THYROID, PORCINE
Product Type Name: HUMAN PRESCRIPTION DRUG
Market Category Name : UNAPPROVED DRUG OTHER
Application Number:
Route Name: ORAL
Substance Name: THYROID, PORCINE
Package Description : 100 TABLET in 1 BOTTLE (0456-0457-01)
Pharm Class: N/A
DEA: N/A
Labeler Name: Forest Laboratories, Inc
Start date: 04-01-1996 / End date: N/A
From CMS Chapter 6 that dictates what constitutes a "covered drug"
"10.9 - DESI Drugs
(Rev. 2, Issued: 07-18-08; Effective/Implementation Date: 07-18-08)
For a drug to be available for reimbursement by a Part D sponsor it must meet the definition of a Part D drug. Section 1860D–2(e)(1) of the Social Security Act (the Act) generally defines a Part D drug to include those drugs that may be dispensed only upon a prescription and that meet the
requirements of section 1927(k)(2) of the Act. Section 1927(k)(2) generally requires that the drug be approved by the FDA or otherwise described under sections 1927(k)(2)(A)(ii) or (A)(iii) of the Act. These provisions address those drugs affected by the Drug Amendments of 1962 (amending the Federal Food, Drug & Cosmetic Act), which require that a new drug be proven effective, as well as safe. FDA"s Drug Efficacy Study Implementation (DESI) evaluates the effectiveness of those drugs that had been previously approved on safety grounds alone. FDA indicates that these drugs, and those identical, related, and similar to them, may continue to be marketed until the administrative proceedings evaluating their effectiveness have been concluded, at which point continued marketing is permitted only if a new drug application (NDA) or abbreviated new drug application (ANDA) is approved. The vast majority of the DESI proceedings have been concluded, but a few are still pending.
The definition of a Part D drug does not include less than effective (LTE) DESI drugs or those identical, related or similar drugs to the LTE DESI drug. As FDA continues to undertake reviews under the DESI program and announces results of its hearings, CMS would expect Part D sponsors to adjust their formularies accordingly, as they should with any other applicable FDA
drug product announcement. If a sponsor discovers the presence of any LTE DESIs on its formulary based on an FDA announcement or otherwise, it should remove these drugs from the formularies on accordance with section 30.3."
From the FDA website:
Proprietary Name: Armour Thyroid
Non-Proprietary Name: THYROID, PORCINE
Product Type Name: HUMAN PRESCRIPTION DRUG
Market Category Name : UNAPPROVED DRUG OTHER
Application Number:
Route Name: ORAL
Substance Name: THYROID, PORCINE
Package Description : 100 TABLET in 1 BOTTLE (0456-0457-01)
Pharm Class: N/A
DEA: N/A
Labeler Name: Forest Laboratories, Inc
Start date: 04-01-1996 / End date: N/A
