IMA White Paper on Stent Controversy

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Report of the Core-Committee for Revision of National List of Essential Medicines November 2015

A Core-Committee was constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India, under the chairmanship of Dr VM Katoch, the then Secretary, Department of Health Research (DHR) and Director General, Indian Council of Medical Research (ICMR), and Dr YK Gupta, Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences (AIIMS) as the Vice Chairman.

The Core-Committee in its initial meetings deliberated and decided on the criteria for inclusion and deletion of medicines in National List of Essential Medicines (NLEM).

The criteria for inclusion of a medicine in NLEM

1. The medicine should be approved/licensed in India
2. The medicine should be useful in disease which is a public health problem in India.
3. The medicine should have proven efficacy and safety profile based on valid scientific evidence.
4. The medicine should be cost effective.
5. The medicine should be aligned with the current treatment guidelines for the disease.
6. The medicine should be stable under the storage conditions in India.When more than one medicine are available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost-effectiveness.
7. Price of total treatment to be considered and not the unit price of a medicine.
8. Fixed Dose Combinations (FDCs) are generally not included unless the combination has unequivocally proven advantage over individual ingredients administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance.
9. The listing of medicine in NLEM is based according to the level of health care, i.e. Primary (P), Secondary (S) and Tertiary (T) because the treatment facilities, training, experience and availability of health care personnel differ at these levels.

The criteria for deletion of a medicine from NLEM is as follows
1. The medicine has been banned in India.
2. There are reports of concerns on the safety profile of a medicine.
3. A medicine with better efficacy or favorable safety profiles and better cost-effectiveness is now available.
4. The disease burden for which a medicine is indicated is no longer a national health concern in India.
5. In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective in Indian context.

The Core-Committee in its first two meetings, discussed in detail the modalities to be followed for revision of NLEM and prepared guiding principles and criteria for the revision of NLEM 2011 as under

Criteria for Inclusion of a Medicine into NLEM 2015 For inclusion of a medicine into NLEM, the medicine should:
1. Be licensed/ approved in the country by Drugs Controller General (India)
2. Be useful in disease which is a public health problem in India
3. Have proven efficacy and safety profile based on valid scientific evidence
4. Be comparatively cost effective
5. Be aligned with the current treatment guidelines for the disease
6. Be stable under the storage conditions in India Medicines recommended under National Health Programmes of India are considered for inclusion in NLEM.

In addition, the following criteria were also considered:
1. When more than one medicine are available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost effectiveness.
2. Price of total treatment to be considered and not the unit price of a medicine
3. FDC are not included unless the combination has unequivocally proven advantage over single compounds administered separately, in terms of increasing efficacy, reducing adverse effects and/or improving compliance
4. The medicine in NLEM will be based at P/S/T level of health care according to treatment facilities and training, experience and availability of health care personnel at these levels

Criteria for Deletion of a Medicine
A medicine will be deleted from NLEM 2011 in the following conditions:
1. The medicine has been banned in India.
2. If there are reports of concerns on the safety profile of a medicine
3. If medicine with better efficacy or favourable safety profile and better cost-effectiveness is now available
4. The disease burden for which a medicine is indicated is no longer a national health concern
5. In case of antimicrobials, if the resistance pattern has rendered a medicine ineffective

DISCUSSION
1. Stents are medicines and included in the drug and cosmetic act

2. Stents have been put under NLIM and hence an essential item and under prise capping
3. All stents cannot be under the same category of drug
4. Stents uses drugs like sirolimus, everolimus, pacitaxil . zotarolimus
5. Most stents are built on a stainless-steel platform, the least-expensive stent material available. Unfortunately, stainless steel is not fully compatible with the human body and implantation usually is followed closely by restenosis and thrombosis. In addition, stainless steel can pose difficulties related to some types of imaging, such as magnetic resonance. Now alternative platform materials such as gold, titanium, cobalt-chromium alloy, tantalum alloy, nitinol and several types of polymers [Silicone, polyethylene and polyurethane] are available.
6. Some polymers are biodegradable, bio-absorbable, or bio-erodible. Â Biodegradable or bio-absorbable stents contain a major component (such as an enzyme or microbe) that degrades quickly enough to make them appropriate for short-term uses. A bio-erodible polymer is a water-insoluble polymer that has been converted into a water-soluble material. Biodegradable materials can form an effective stent coating because they can be mixed with an anti-restinotic drug and will degrade within a few weeks, thus releasing the drug into the surrounding tissue and reducing the risk of restenosis. Examples of biodegradable polymers are: polyesters, polyorthoesters and polyanhydrides. Collagen is also very biocompatible and reduces the rate of restenosis and thrombosis. In addition, anticoagulants and fibrinolytic agents bound to the collagen can aid in drug delivery.

Issues

Can all stents be under NLEM?

No. As per NLEM guidelines when more than one medicine is available from the same therapeutic class, preferably one prototype/ medically best suited medicine of that class to be included after due deliberation and careful evaluation of their relative safety, efficacy, cost effectiveness. Stents needs to be classified in different groups and in each group one of them must be in NLEM and the rest in non NLEM.

Will the cost of procedure increase to compensate for the loss of profit in stents selling?

No: As per NLEM guidelines the price of total treatment to be considered and not the unit price of a medicine

Are non NLEM stents superior to NLEM stents?

No. As per NLEM guidelines a drug will be deleted from NLEM if there are reports of concerns on the safety profile of a medicine and if a drug with better efficacy or favourable safety profile and better cost-effectiveness is now available.

All NLEM drugs has to be efficacious or proves safety and quality. NON NLEM should be non- inferior to the NLEM drugs. If a non NLEM drug is superior to NLRM drug is likely to enter into NLEM category.

Does costly means better?

NLEM drugs will be cheaper and NON NLEM though costly will be non-inferior to NLEM drugs.

What do you mean by high end stents?

Weather low end or high end each will be a class. From each class one drug must be in NLEM.

Can hospital make profits from stents?

As per NPPA clarification today: NPPA didn’t take price to hospitals(PTH) as price to retailers(PTR) & considered hospitals out of stents ‘trade channel’ for price fixing. That means there will be margins for the distributors but not fort the hospitals. As per AIMED the hospitals need to make income from procedure and compete with other hospitals & not from medical devices used in the procedure. Once hospitals won’t make profits on Stents their procurement will shift back to the buying price of product and quality.

Can hospitals compel a patient to buy a drug only from hospital inventory?

A: No. There are many state government. NCDRC and cost decision against it.

If stent companies do not sponsor the conference who will?

A: Why should drugs or stent companies sponsor conferences. Either the doctors must pay for the learning and contribute or the hospitals should sponsor out of their profits. Now a days in any way no speciality conference delegation fess is less than 10,000/

How do we ensure that Indian stents are good?

It is not our job to decide good or bad. Any stent approved by DCGI is good. The responsibility is on the DCGI and the expert committee under Technical drug advisory committee. In the Anuradha Saha Supreme Court case the apex court said one need to follow the label cleared by the DCGI. Also the DCGI PvPi program (9717776514 phone number) if the department receives any report of side effects of any device the device immediately can be taken off the market. Till today the very fact India stents can be marketed means no adverse effects have been notified to PvPI so far.

What is IMA stand on routine pharma drugs?

Write NLEM drugs and inform the patient about the reason if writing non NLEM drugs. IMA campaign is Write CAPITAL write NLEM.

With this large segment of the society will be covered with affordable health care. Those who can afford can go for newer non-superior drugs with some special advantages for example longer acting, mouth dissolvable, nano- technology, more tasty formulations etc.

How much a cardiologist charge for the implantation?

As per MCI only thing required is transparency and pre- procedure declaration. As per CEA, rates will be defined by the state government in consultation with organisations including the IMA.

What is the latest by NPPA in stents?

Its today dated 20.2.2107

Dr KK Aggarwal
National President IMA and HCFI