Securing the Benefits of Medical Innovation for Seniors: The Role of Prescription Drugs and Drug Coverage. Appendix - Selected FDA Approved Drugs and Biologics with Restricted Access in Other Countries

07/01/2002

Indication

Product

Market*

Nature of Government Plan Restriction**

Comment

Acne

Azelaic acid (Azelex)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 9/13/95)

Alzheimer’s

Donepezil (Aricept)

Ontario, Canada

Restricted Coverage

Coverage is restricted to patients who have mild to moderate Alzheimer’s and have demonstrated benefit after 3 months of treatment.

Quebec, Canada

Not Covered

Not listed on Quebec’s prescription drug formulary.

New Zealand

Not Covered

Not approved for coverage by PHARMAC of New Zealand.

Allergies

Azelastine (Astelin)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 11/1/96)

Pemirolast (Alamast)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 9/24/99)

Amyotrophic Lateral Sclerosis

Riluzole (Rilutek)

Canada

Not Covered

Riluzole has not been approved for use in Canada.(1)

Arthritis/Pain

Celecoxib (Celebrex)

Ontario, Canada

Restricted Coverage

Coverage is restricted to patients with arthritis who have failed an adequate trial of other pain medications and have a history of ulcer or gastro-intestinal bleeding.

New Zealand

Not Covered

Not covered for use by PHARMAC of New Zealand.

Etanercept (Enbrel)

Britain

Restricted Coverage

Britain’s National Health Service (NHS) covers etanercept only as a second line therapy for children aged 4-17 with non-responsive arthritis in at least 5 joints and in adults with active rheumatoid arthritis who are nonresponsive to other medications.

Japan

Not Approved

Not approved for use in Japan.

Ontario, Canada

Not Covered

Not listed on Ontario’s prescription drug formulary.

New Zealand

Not Covered

Not covered for use by PHARMAC of New Zealand.

Infliximab (Remicade)

Britain

Restricted Coverage

Britain’s NHS covers infliximab only as a second line therapy in combination with methotrexate for adults with active rheumatoid arthritis who are not responsive to other medications.

Ontario, Canada

Not Covered

Not listed on Ontario’s prescription drug formulary.

New Zealand

Not Covered

Not covered for use by PHARMAC of New Zealand.

Rofecoxib (Vioxx)

New Zealand

Not Covered

Available since March 2000, but not approved for coverage by PHARMAC.

Australia

Restricted Coverage

Coverage is restricted to symptomatic treatment of patients with osteoarthritis

British Columbia, Canada

Restricted Coverage

Coverage is restricted to patients who have failed to benefit from acetaminophen and at least three other funded non-steroidal anti-inflammatory drugs (NSAIDs).

New Brunswick and Saskatchewan, Canada

Restricted Coverage

Coverage is restricted to patients who meet one of the following criteria: age 65+, past history of ulcers, concurrent warfarin therapy, concurrent prednisone therapy, or failure or intolerance to at least two other NSAIDs.

Ontario, Canada

Restricted Coverage

Coverage is restricted to a maximum daily dose of 25 mg for the treatment of osteoarthritis. Prior therapy with acetaminophen for several weeks must have failed, and the patient must have a history of documented clinically significant ulcer or GI bleed, or failure or intolerance to at least three NSAIDs.

Tramadol (Ultram)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 3/3/95)

Asthma

Montelukast (Singulair)

New Zealand

Not Covered

Available since 1998, but not covered.

Australia

Not Covered

Currently not covered, but negotiations for listing are on-going.

Belgium

Not Covered

Available, but not covered.

Finland

Not Covered

Pediatric strengths are available, but not covered.

British Columbia, Canada

Not Covered

Coverage was restricted in 1999 and discontinued in 2001

Newfoundland, Canada

Restricted Coverage

Coverage is restricted to patients uncontrolled on therapeutic doses of inhaled corticosteroids who have failed to respond to or have a contraindication to zafirlukast.

Nova Scotia, Canada

Restricted Coverage

Coverage is restricted to 4 and 5 mg chewable format for patients younger than 12.

Ontario and New Brunswick, Canada

Not Covered

Available, but not covered. Not listed on formulary.

Prince Edward Island, Canada

Restricted Coverage

Coverage is restricted to patients on concurrent steroid therapy or patients not well controlled with inhaled corticosteroids.

Saskatchewan, Canada

Restricted Coverage

Coverage is restricted to patients with Special Authorization for adjunctive treatment of asthma who are not well controlled with inhaled corticosteroids.

Zileuton (Zyflo)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 12/9/96)

Benign Prostatic Hyperplasia

Finasteride (Proscar)

New Zealand

Not Covered

Available, but not listed on formulary. (FDA approved 3/20/98)

Ontario, Canada

Not Covered

Not listed on Ontario’s prescription drug formulary.

Cancer

Bexarotene (Targretin)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 12/29/99)

Japan

Not Approved

Not approved for use in Japan.

New Zealand

Not Approved

Not approved for use by Medsafe of New Zealand. (FDA approved 12/29/99)

Imatinib (Gleevec or Glivec)

Britain

Restricted Coverage

In a preliminary assessment of imatinib prepared for Britain’s National Institute for Clinical Excellence (NICE), it is recommended that imatinib only be used for treatment of accelerated phase of chronic myeloid leukemia and not for the routine treatment of the chronic or blast crisis stages. This is a preliminary recommendation that has not yet been finalized.

New Zealand

Not Covered

Not covered for use by PHARMAC of New Zealand.

Interlukin-2

Canada

Restricted Coverage

Interlukin-2 is generally not covered in Canada for treatment of metastatic kidney cancer.(2)

Irinotecan (Camptosar)

Britain

Restricted Coverage

Britain’s NHS restricts irinotecan coverage, either alone or in combination, as a first-line treatment for colorectal cancer. Reimbursement for this drug is permitted if other treatments fail.

New Zealand

Not Covered

Available, but not covered.(3)

Oxaliplatin (Eloxatin)

Britain

Restricted Coverage

Britain’s NHS restricts coverage for oxaliplatin as a first-line treatment for colorectal cancer, except in patients whose cancer has spread to the liver and may become operable with treatment. Reimbursement for this drug is permitted if other treatments fail.

Rituximab (Rituxan)

Britain

Restricted Coverage

Britain’s NHS restricts coverage of rituximab to last-line treatment for stage 3 or 4 non-Hodgkin’s lymphoma. Reimbursement for rituximab is permitted only after conventional chemotherapy agents have failed.

Ontario, Canada

Not Covered

Not listed on Ontario’s drug formulary.

New Zealand

Not Covered

Not covered for use by PHARMAC of New Zealand.

Tratuzumab (Herceptin)

Britain

Restricted Coverage

Britain’s NHS restricts coverage of tratuzumab to women with advanced HER2 positive breast cancer who meet specific clinical criteria.

Raltitrexed (Tomudex)

Britain

Not Covered

Britain’s NHS restricts does not cover raltitrexed for use outside of appropriately designed clinical studies.

Other new cancer drugs

Austrailia

Delays in Approval

In Austrailia, cancer treatment drugs take 3.5 times as long to approve as anti-HIV therapies. The Therapeutic Goods Administration (TGA) is markedly slower than the U.S. FDA in getting both groups of medications on the market.(4)

New Zealand

Not Covered

In four of New Zealand’s six regional cancer centers, patients have been denied access to new cancer treatments due to lack of funding in the regional health care system.(5)

Crohn’s Disease

Infliximab (Remicade)

Japan

Unavailable

 

Cushing’s Syndrome

Corticorelin (Acthrel)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 5/23/96)

Depression

Bupropion (Wellbutrin)

Canada

Restricted Coverage

Covered as a limited use benefit only in patients who are unresponsive to other antidepressants under Health Canada’s Non-Insured Health Benefits Program.

Fluvoxamine (Luvox)

New Zealand

Not Covered

Not approved for coverage by PHARMAC of New Zealand.

All SSRI’s

Japan

Delays in Approval

The first SSRI marketed in Japan, fluvoxamine, was launched in 1999.(6) SSRI’s were first approved for sale by the FDA in 1987.

Diabetes

Rosiglitazone (Avandia)

Ontario, Canada

Not Covered

Not listed on Ontario’s prescription drug formulary.

New Zealand

Not Covered

Not approved for coverage by PHARMAC of New Zealand.

End Stage Renal Disease (ESRD)

Selvamer (Renagel)

Japan

Not Approved

Not approved for use in Japan

New Zealand

Not Approved

Not approved for use by Medsafe of New Zealand. (FDA approved 11/2/98)

Fetal Respiratory Distress

Poractant Alpha (Curosurf)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 11/18/99)

GI and Ulcer

Amlexanax (Aphthasol)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 12/17/96)

Omeprazole (Prilosec)

Canada

Restricted Coverage

Implementation of resource based pricing caused physicians to replace omeprazole with cimetidine, which is less effective in preventing gastric bleeding

Rabeprazole (Aciphex)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 8/19/99)

High Cholesterol

Simvastatin (Zocor)

New Zealand

Restricted Coverage prior to Feb. 2001

Until the expiration of simvastatin’s patent, coverage for simvastatin was restricted to patients with a >20%, 5-year risk of cardiovascular disease who met minimum cholesterol thresholds.

Australia

Restricted Coverage

Coverage restrictions are complex, including the failure of 6 weeks prior dietary therapy.

Atorvastatin (Lipitor)

New Zealand

Restricted Coverage

As of July 1, 2002, coverage of lipitor is restricted to patients who receive special authority approval from the government. Patients who have not approved special authority must switch to an alternate statin.

Lovastatin (Mevacor)

New Zealand

Not Covered

Not covered for use by PHARMAC of New Zealand.

Pravastatin (Pravachol)

New Zealand

Not Covered

Not covered for use by PHARMAC of New Zealand.

Hyperpara-thyroidism

Paricalcitol (Zemplar)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 4/17/98)

Hypertension

Fenoldopam (Corlopam)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 9/23/97)

Losartan Potassium (Cozaar)

New Zealand

Restricted Coverage

Only specialists (cardiologists) can initiate therapy, and then only if the patient suffers from congestive heart failure and treatment attempts with at least two types of ACE inhibitors have not been tolerated.

Australia

Not Covered

The product was covered approximately 6 years ago, but the government instituted a reference price/reimbursement limit that was commercially unacceptable. It is no longer offered on the market.

Canada (British Columbia, Ontario, New Brunswick, Newfoundland)

Restricted Coverage

Generally restricted to patients who cannot tolerate ACE inhibitors.

Losartan Potassium/ hydrochloro-thiazide (Hyzaar)

British Columbia, Canada

Restricted Coverage

Coverage is restricted to patients who have experienced a cough with ACE inhibitors and also require a diuretic.

New Brunswick, and Newfoundland, Canada

Restricted Coverage

A “special authorization” may be considered if the doctor justifies the need. There are no published criteria.

Ontario, Canada

Restricted Coverage

Coverage is restricted to patients who cannot tolerate beta-blockers or in whom beta-blockers and diuretics alone are not effective; and who have experienced adverse effects with ACE inhibitors, and who require the addition of a diuretic to achieve adequate hypertension control.

Moexipril (Univasc)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 4/19/95)

Nisoldipine (Sular)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 2/2/95)

Valsartan (Diovan)

Ontario, Canada

Restricted Coverage

Restricted to patients who cannot tolerate diuretics, beta-blockers, and ACE inhibitors.

New Zealand

Not Covered

Not approved for coverage by PHARMAC of New Zealand.

Enalapril mal-eate/HCTZ (Vaseretic)

British Columbia, Canada

Restricted Coverage

Coverage is listed as a “partial benefit” under Pharmacare’s Reference Drug Pricing (RDP) program.

 

Infectious Disease

Albendazole (Albenza)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 6/11/96)

Ivermectin (Stromectol)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 11/22/96)

Rifapentine (Priftin)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 6/22/98)

Insomnia

Zaleplon (Sonata)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 8/13/99)

Eye Disorders

Dorzolamide (Trusopt)

New Zealand

Restricted Coverage

Specialist required to initiate therapy, and restricted only to patients with primary open-angle glaucoma with very high intra-ocular pressure that cannot be controlled using other therapies.

Loteprednol (Lotemax)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 3/9/98)

Migraine Headache

Rizatriptan (Maxalt)

New Zealand

Not Covered

Available since 1999, but not approved for use by PHARMAC.

Australia

Not Covered

Not available.

Belgium

Not Covered

Available, but not covered.

France

Not Covered

Not available.

Portugal

Not Covered

Available, but without reimbursement.

Alberta, Canada

Restricted Coverage

Coverage is restricted to patients 18-24 years of age for treatment of acute migraine attacks where standard therapy has failed. Special authorization is required for treatment of acute migraine attacks in patients 65+ where standard therapy has failed and for those who were using Maxalt prior to turning 65.

Nova Scotia, Canada

Restricted Coverage

Coverage is restricted to patients experiencing moderate migraines (if other therapies have not been effective) or severe migraines.

Ontario, Canada

Not Covered

Not listed on Ontario’s prescription drug formulary.

Saskatchewan, Canada

Restricted Coverage

Coverage is restricted to patients when other standard therapies, such as analgesics and/or ergotamine, have failed. Eligibility is restricted to beneficiaries 18-65 years of age.

Multiple Sclerosis (MS)

-Interferon (Avonex, Betaseron)

Glatiramer acetate (Copaxone)

Britain

Not Covered

Britain’s NHS does not cover -Interferon and glatiramer acetate for the treatment of MS.

Osteoporosis

Alendronate (Fosamax)

New Zealand

Restricted Coverage

Only specialists can initiate this therapy, and then only if the patient has suffered one previous, significant osteoporotic vertebral or hip fracture (radiologically demonstrated).

Australia

Restricted Coverage

Coverage is restricted to patients who have sustained a fracture due to minimal trauma and established the existence of osteoporosis.

Belgium

Restricted Coverage

Coverage is restricted to patients with fracture or low bone density.

France

Restricted Coverage

Coverage is restricted to patients with fracture.

Italy

Restricted Coverage

Coverage is restricted to patients with vertebral or hip fracture.

Alberta, Canada

Restricted Coverage

Coverage is restricted to patients with vertebral of other fractures. Special authorization is granted for 24 months.

British Columbia, Canada

Restricted Coverage

Coverage is restricted to patients who have fractures due to osteoporosis, and an adequate trial of etidronate (at least one year) that has failed to prevent fractures.

Newfoundland, Canada

Restricted Coverage

Coverage is restricted to patients with low bone mass or fractures, or women who have failed or are intolerant to hormone replacement therapy (HRT).

Nova Scotia, Canada

Restricted Coverage

Coverage is restricted to patients who have a fracture, and have failed HRT. Other restrictions also apply.

Ontario, Canada

Restricted Coverage

Coverage is restricted to postmenopausal women who have failed to respond to etidronate or experienced fracture during etidronate therapy

Saskatchewan, Canada

Restricted Coverage

Coverage is restricted to patients who have not responded to etidtronate or didrocal and have new fractures or Paget’s disease.

Raloxifene (Evistia)

Ontario, Canada

Restricted Coverage

Coverage is restricted to patients who have failed to respond to etidronate or experienced a new fracture

Quebec, Canada

Not Covered

Not listed on Quebec’s prescription drug formulary

New Zealand

Not Covered

Not covered for use by PHARMAC of New Zealand

Reproductive Health

Ganirelix Acetate (Antagon)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 7/29/99)

Seizures

Levetirace-tam (Keppra)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 11/30/99)

Tiagabine (Gabitril)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 9/30/97)

Vascular Disease

Cilostazol (Pletal)

Canada

Not Approved

Not approved for use by Health Canada. (FDA approved 1/15/99)

* This table is not intended to be a comprehensive list of markets where access to selected medications is limited. There may be additional countries/markets that restrict access to the medications listed.

** Sources include government websites, reports in news media, communications with pharmaceutical manufacturers, peer-reviewed literature and other sources. See the final page of the appendix for a list of government websites used as source material. Not all examples have been independently verified for all countries listed.

(1) ALS Society of Canada. Drug Trials. www.als.ca/manual-whatisals-drugtrials.shtml Accessed on July 8, 2002.

(2) Cancer Guide. Steve Dunn’s Kidney Cancer Page. www.cancerguide.org/kidney.html Accessed on July 8, 2002.

(3) The Daily News (New Plymouth). Society outraged at cancer drug funding. May 19, 2001.

(4) The Mercury Hobart. Alarm at cancer drug lag. December 2, 2000.

(5) The Dominion (Wellington). Cancer patients miss out on new drugs. May 12, 2001.

(6) Tajima O. Mental health care in Japan: recognition and treatment of depression and anxiety disorders. Journal of Clinical Psychiatry. 62(suppl 13), 39-44, 2001.

 

Sources:

Canada

Health Canada. Non-insured Health Benefits Drug Benefit List. www.hc-sc.gc.ca/fnihb/nihb/index.htm Accessed on July 9, 2002.

Health Canada Online. Drug Product Database. www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/dpd.html Accessed on July 9, 2002.

Ontario Ministry of Health and Long Term Care. Ontario Drug Benefit Formulary, Number 37. March 7, 2001. www.gov.on.ca/health/english/program/drugs/odbf/odbf_mn.html Accessed on July 9, 2002.

Quebec Prescription Drug Insurance Plan. List of Medications. www.ramq.gouv.qc.ca/crc/eng/cit/assmed/cond.shtml Accessed on July 9, 2002.

Great Britain

British National Formulary (BNF). www.bnf.org Accessed on July 9, 2002.

National Institute for Clinical Excellence. Press Releases. www.nice.org.uk Accessed on July 9, 2002.

New Zealand

Medsafe. Consumer Medical Information. www.medsafe.govt.nz Accessed on July 9, 2002.

Pharmaceutical Management Agency (PHARMAC). New Zealand Pharmaceutical Schedule. www.pharmac.govt.nz Accessed on July 9, 2002.

United States

Food and Drug Administration (FDA). www.fda.gov Accessed on July 9, 2002.

View full report

Preview
Download

"innovation.pdf" (pdf, 708.29Kb)

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®