New Guidelines for Injectable GLP-1 Receptor Agonists Under CGHS and CS(MA) Rules

Introduction

New guidelines have been issued for the prescription of injectable GLP-1 receptor agonists, including Tirzepatide (Mounjaro) and Semaglutide, under the Central Government Health Scheme (CGHS) and the Central Services (Medical Attendance) Rules, 1944. These updated directives aim to ensure the appropriate and safe use of these advanced medications for eligible beneficiaries.

Understanding Injectable GLP-1 Receptor Agonists

Injectable GLP-1 receptor agonists represent a significant advancement in managing chronic health conditions like Type-2 Diabetes Mellitus and obesity. These medications work by mimicking the action of naturally occurring hormones, helping to regulate blood sugar levels and promote weight loss. Their inclusion under CGHS and CS(MA) rules signifies a commitment to providing beneficiaries with access to modern therapeutic options.

Key Changes and Additions

The Ministry of Health & Family Welfare, in consultation with the Directorate of CGHS, has thoroughly reviewed the use of these injectable medications. Following expert recommendations and with the approval of the Competent Authority, it has been decided to officially include Injection Tirzepatide (Mounjaro) in the Online List of Restricted Drugs under the CGHS. This addition, alongside Injection Semaglutide, means that both medications will now be prescribed strictly according to the detailed guidelines provided.

Eligibility Criteria for Beneficiaries

To ensure that these potent medications are used for the right patients, specific eligibility criteria have been established. Beneficiaries can only be prescribed injectable GLP-1 receptor agonists if they meet one of the following conditions:

• A Body Mass Index (BMI) of 35 kg/m² or higher.
• A BMI of 32.5 kg/m² or higher, coupled with one or more of the following co-existing conditions:
  • Uncontrolled Type-2 Diabetes Mellitus, even after treatment with Metformin and at least two other oral anti-diabetic drugs.
  • Severe Obstructive Sleep Apnoea.
  • Existing Atherosclerotic Cardiovascular Disease.
  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
  • Chronic Kidney Disease (CKD).

Contraindications: When Not to Prescribe

For the safety of beneficiaries, several contraindications have been clearly outlined. Injectable GLP-1 receptor agonists should not be prescribed if a beneficiary has:

• A history of pancreatitis.
• A personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia Type-2 (MEN2).
• Is currently pregnant or breastfeeding.
• Severe Non-Proliferative Diabetic Retinopathy (NPDR) or Proliferative Diabetic Retinopathy (PDR).
• Severe gastroesophageal reflux disease (GERD), gastroparesis, inflammatory bowel disease, or has previously undergone metabolic or bariatric surgery.

Prerequisites for Initiating Treatment

Before a beneficiary can begin treatment with these injectable medications, certain preparatory steps must be completed and certified by the treating specialist. These prerequisites emphasize a holistic approach to health management:

• The beneficiary must have actively undertaken lifestyle modifications.
• Comprehensive dietary counselling must have been provided.
• A supervised physical activity program should have been followed.
• Crucially, the beneficiary must have demonstrated compliance with these measures for a minimum period of three months.

Prescribing Authority and Duration

To maintain oversight and ensure expert medical judgment, specific guidelines are in place regarding who can prescribe these medications and for how long. Prescriptions are to be issued exclusively by an Endocrinologist or an Internal Medicine Specialist working within a Government Hospital. Furthermore, each prescription must be endorsed by the concerned Head of Department. The initial approval for these medications is valid for six months. Any continuation of treatment beyond this period will necessitate a fresh recommendation from the treating specialist and a new endorsement from the Head of Department.

Monitoring and Follow-up

Consistent monitoring is vital to track treatment efficacy and patient safety. Beneficiaries will require monthly follow-up appointments for the first three months of treatment. Following this initial period, follow-up appointments will be scheduled every three months thereafter. The treating specialist is responsible for meticulously documenting key aspects of the patient’s response and well-being, including:

• Observed weight reduction.
• Overall clinical response to the therapy.
• Any gastrointestinal adverse effects experienced.
• Any evidence suggesting pancreatitis.
• Signs of muscle wasting.
• Any other adverse drug reactions.

Continuation of the GLP-1 receptor agonist therapy will be contingent upon the documented presence of clinical benefit and a satisfactory safety profile.

Ensuring Strict Implementation

The Additional Directors of CGHS are tasked with the responsibility of ensuring the stringent implementation of these newly issued guidelines across all CGHS Wellness Centres and CGHS empanelled Health Care Organisations within their respective jurisdictions. Any deviation from these directives will be viewed with seriousness, underscoring the importance of adhering to the prescribed protocols for the benefit and safety of all eligible beneficiaries. These instructions are effective immediately upon their issuance.

Important Information

Note: If any of Sl. Nos. 3-7 are marked "Yes", GLP-1 Receptor Agonist therapy shall not be prescribed.

Conclusion

These updated guidelines for injectable GLP-1 receptor agonists under CGHS and CS(MA) rules provide a clear framework for their appropriate use. By adhering to the defined eligibility, contraindications, prerequisites, and monitoring protocols, healthcare providers can ensure these valuable treatments are administered safely and effectively to beneficiaries.

Frequently Asked Questions

What are injectable GLP-1 receptor agonists?

These are medications that mimic natural hormones to help manage Type-2 Diabetes and obesity by regulating blood sugar and promoting weight loss.

Which new medication has been added to the CGHS list?

Injection Tirzepatide (Mounjaro) has been added to the Online List of Restricted Drugs under CGHS.

What are the BMI requirements for eligibility?

Beneficiaries need a BMI of at least 35 kg/m², or a BMI of 32.5 kg/m² along with specific co-existing medical conditions.

Can anyone with Type-2 Diabetes get these injections?

No, only if the diabetes is uncontrolled despite treatment with Metformin and at least two other oral anti-diabetic drugs, and the BMI criteria are met.

What are some key contraindications for these medications?

A history of pancreatitis, personal/family history of certain thyroid cancers, pregnancy, severe diabetic retinopathy, and severe gastrointestinal issues are contraindications.

How long must lifestyle modifications be in place before starting treatment?

Beneficiaries must have complied with lifestyle modifications, dietary counselling, and supervised physical activity for at least three months.

Who is authorized to prescribe these injectable GLP-1 receptor agonists?

Only an Endocrinologist or an Internal Medicine Specialist from a Government Hospital can prescribe these medications.

How long is a prescription for these drugs valid?

A prescription is valid for six months. After this period, a fresh recommendation and endorsement are required for continuation.

What kind of follow-up is required for patients on this therapy?

Monthly follow-ups are needed for the first three months, followed by follow-ups every three months thereafter.

What happens if there is a deviation from these guidelines?

Any deviation from these guidelines will be viewed seriously by the authorities.